Asthma

Asthma is not well controlled in about half of patients with the disease in the UK and Europe, increasing the risk of hospital admission and severe illness, and increasing healthcare costs. 

Now, the authors of a new study have reported that poorly controlled asthma is also associated with a higher carbon footprint, eight times higher than that of well-controlled asthma and equivalent to the greenhouse gas emissions produced by more than 124,000 homes each year in the UK.

The study was published in the journal Thorax and is part of the Healthcare-Based Environmental Cost of Treatment (CARBON) programme, which aims to provide a broader understanding of the carbon footprint associated with respiratory care. 

John Bell, BMBCh, medical director of BioPharmaceuticals Medical, AstraZeneca, and co-author of the study, said that he was surprised by the scale to which poorly controlled asthma contributed to the overall carbon footprint of asthma care. “This suggests that suboptimal asthma care is not just a public health issue, but also one which has environmental consequences,” he said.

Improving the care of asthma patients could help the NHS meet its net zero target, the authors suggested.
 

SABA – Largest Contributor to Asthma-Related Greenhouse Gases

Healthcare is a major contributor to greenhouse gas emissions. In 2020, the NHS set an ambitious target of reducing its carbon footprint by 80% over the next 15 years, with the aim of reaching net zero by 2045.

To estimate the environmental footprint of asthma care in the UK, the researchers retrospectively analyzed anonymized data of 236,506 people with asthma submitted to the Clinical Practice Research Datalink between 2008 and 2019. 

Greenhouse gas (GHG) emissions, measured as carbon dioxide equivalent (CO2e), were then estimated for asthma-related medication use, healthcare resource utilization, and severe exacerbations.

Well-controlled asthma was considered as having no episodes of severe worsening symptoms and fewer than three prescriptions of short-acting beta-agonists (SABAs) reliever inhalers in a year. Poorly controlled asthma included three or more SABA canister prescriptions or one or more episodes of severe worsening symptoms in a year.

Almost one in two patients with asthma (47.3%) were categorized as being poorly controlled. 

The researchers estimated the overall carbon footprint attributed to asthma care when scaled to the entire UK asthma population was 750,540 tonnes CO2e/year, with poorly controlled asthma contributing to excess GHG emissions of 303,874 tonnes CO2e/year. 

“Poorly controlled asthma generated three-fold higher greenhouse gas emissions per capita compared with well-controlled asthma, when taking into account GHG emissions related to all aspects of asthma care, including routine prescribing and management,” Dr. Bell explained. It also generated eight-fold higher excess per capita carbon footprint compared to well-controlled asthma.

SABA relievers represented the largest contributors to per capita asthma-related GHG emissions, accounting for more than 60% of overall GHG emissions and more than 90% of excess GHG emissions. The remainder was mostly due to healthcare resource utilization, such as GP and hospital visits, required to treat severe worsening symptoms.

The researchers acknowledged various limitations to their findings, including that the study results were largely descriptive in nature. And factors other than the level of asthma symptom control, such as prescribing patterns, may also have contributed to high SABA use.
 

Couple Optimized Patient Outcomes With Environmental Targets

With inappropriate SABA use having emerged as the single largest contributor to asthma care-related GHG emissions, improving this care could achieve substantial carbon emissions savings and help the NHS meet its net zero target, the authors explained. 

This improvement could include the adoption of the Global Initiative for Asthma (GINA) treatment strategies that, since 2019, no longer recommends that SABAs are used alone as the preferred reliever for acute asthma symptoms, the authors wrote. 

However, the National Institute for Health and Care Excellence (NICE) asthma guidelines still recommend SABA alone as a reliever therapy.

On the other hand, the Primary Care Respiratory Society (PCRS) highlights on its website that the Medicines and Healthcare Products Regulatory Agency (MHRA) had approved the use of a dual (inhaled corticosteroid/formoterol) combination treatment to be used as a reliever therapy for people aged 12 and over.

“In the UK, this new therapy option does not yet sit within an approved national guideline as NICE last updated its treatment pathway in 2020. We await a new national asthma guideline but do not anticipate this new joint approach between NICE, BTS [British Thoracic Society], and SIGN [Scottish Intercollegiate Guidelines Network] to publish until 2024,” the society wrote.

Dr. Bell explained that the carbon footprint of asthma care increased with higher socio-economic deprivation. “Thus, targeting suboptimal care to areas of higher deprivation could help improve patient outcomes and address health inequities, with the additional benefit of reducing the overall carbon footprint of asthma care,” he said.

This coupling of optimized patient outcomes with environmental targets to decrease GHG emissions could be extended to other chronic progressive diseases, particularly those associated with multi-morbidities, the authors wrote.

Dr. Andy Whittamore, MBBS, clinical lead at Asthma + Lung UK, who was not involved in the research, said: “This study highlights that high levels of uncontrolled asthma not only put thousands of people at risk of life-threatening asthma attacks, but also have a detrimental effect on the environment. It’s important to point out that people shouldn’t stop taking their inhalers because they are worried about the environment. The best thing for the environment is to keep your asthma under control,” he emphasized.

Please refer to the study for full study author disclosures.Dr. Hicks has disclosed no relevant financial relationships.

A version of this article appeared on Medscape UK.

Asthma is not well controlled in about half of patients with the disease in the UK and Europe, increasing the risk of hospital admission and severe illness, and increasing healthcare costs. 

Now, the authors of a new study have reported that poorly controlled asthma is also associated with a higher carbon footprint, eight times higher than that of well-controlled asthma and equivalent to the greenhouse gas emissions produced by more than 124,000 homes each year in the UK.

The study was published in the journal Thorax and is part of the Healthcare-Based Environmental Cost of Treatment (CARBON) programme, which aims to provide a broader understanding of the carbon footprint associated with respiratory care. 

John Bell, BMBCh, medical director of BioPharmaceuticals Medical, AstraZeneca, and co-author of the study, said that he was surprised by the scale to which poorly controlled asthma contributed to the overall carbon footprint of asthma care. “This suggests that suboptimal asthma care is not just a public health issue, but also one which has environmental consequences,” he said.

Improving the care of asthma patients could help the NHS meet its net zero target, the authors suggested.
 

SABA – Largest Contributor to Asthma-Related Greenhouse Gases

Healthcare is a major contributor to greenhouse gas emissions. In 2020, the NHS set an ambitious target of reducing its carbon footprint by 80% over the next 15 years, with the aim of reaching net zero by 2045.

To estimate the environmental footprint of asthma care in the UK, the researchers retrospectively analyzed anonymized data of 236,506 people with asthma submitted to the Clinical Practice Research Datalink between 2008 and 2019. 

Greenhouse gas (GHG) emissions, measured as carbon dioxide equivalent (CO2e), were then estimated for asthma-related medication use, healthcare resource utilization, and severe exacerbations.

Well-controlled asthma was considered as having no episodes of severe worsening symptoms and fewer than three prescriptions of short-acting beta-agonists (SABAs) reliever inhalers in a year. Poorly controlled asthma included three or more SABA canister prescriptions or one or more episodes of severe worsening symptoms in a year.

Almost one in two patients with asthma (47.3%) were categorized as being poorly controlled. 

The researchers estimated the overall carbon footprint attributed to asthma care when scaled to the entire UK asthma population was 750,540 tonnes CO2e/year, with poorly controlled asthma contributing to excess GHG emissions of 303,874 tonnes CO2e/year. 

“Poorly controlled asthma generated three-fold higher greenhouse gas emissions per capita compared with well-controlled asthma, when taking into account GHG emissions related to all aspects of asthma care, including routine prescribing and management,” Dr. Bell explained. It also generated eight-fold higher excess per capita carbon footprint compared to well-controlled asthma.

SABA relievers represented the largest contributors to per capita asthma-related GHG emissions, accounting for more than 60% of overall GHG emissions and more than 90% of excess GHG emissions. The remainder was mostly due to healthcare resource utilization, such as GP and hospital visits, required to treat severe worsening symptoms.

The researchers acknowledged various limitations to their findings, including that the study results were largely descriptive in nature. And factors other than the level of asthma symptom control, such as prescribing patterns, may also have contributed to high SABA use.
 

Couple Optimized Patient Outcomes With Environmental Targets

With inappropriate SABA use having emerged as the single largest contributor to asthma care-related GHG emissions, improving this care could achieve substantial carbon emissions savings and help the NHS meet its net zero target, the authors explained. 

This improvement could include the adoption of the Global Initiative for Asthma (GINA) treatment strategies that, since 2019, no longer recommends that SABAs are used alone as the preferred reliever for acute asthma symptoms, the authors wrote. 

However, the National Institute for Health and Care Excellence (NICE) asthma guidelines still recommend SABA alone as a reliever therapy.

On the other hand, the Primary Care Respiratory Society (PCRS) highlights on its website that the Medicines and Healthcare Products Regulatory Agency (MHRA) had approved the use of a dual (inhaled corticosteroid/formoterol) combination treatment to be used as a reliever therapy for people aged 12 and over.

“In the UK, this new therapy option does not yet sit within an approved national guideline as NICE last updated its treatment pathway in 2020. We await a new national asthma guideline but do not anticipate this new joint approach between NICE, BTS [British Thoracic Society], and SIGN [Scottish Intercollegiate Guidelines Network] to publish until 2024,” the society wrote.

Dr. Bell explained that the carbon footprint of asthma care increased with higher socio-economic deprivation. “Thus, targeting suboptimal care to areas of higher deprivation could help improve patient outcomes and address health inequities, with the additional benefit of reducing the overall carbon footprint of asthma care,” he said.

This coupling of optimized patient outcomes with environmental targets to decrease GHG emissions could be extended to other chronic progressive diseases, particularly those associated with multi-morbidities, the authors wrote.

Dr. Andy Whittamore, MBBS, clinical lead at Asthma + Lung UK, who was not involved in the research, said: “This study highlights that high levels of uncontrolled asthma not only put thousands of people at risk of life-threatening asthma attacks, but also have a detrimental effect on the environment. It’s important to point out that people shouldn’t stop taking their inhalers because they are worried about the environment. The best thing for the environment is to keep your asthma under control,” he emphasized.

Please refer to the study for full study author disclosures.Dr. Hicks has disclosed no relevant financial relationships.

A version of this article appeared on Medscape UK.

Asthma is not well controlled in about half of patients with the disease in the UK and Europe, increasing the risk of hospital admission and severe illness, and increasing healthcare costs. 

Now, the authors of a new study have reported that poorly controlled asthma is also associated with a higher carbon footprint, eight times higher than that of well-controlled asthma and equivalent to the greenhouse gas emissions produced by more than 124,000 homes each year in the UK.

The study was published in the journal Thorax and is part of the Healthcare-Based Environmental Cost of Treatment (CARBON) programme, which aims to provide a broader understanding of the carbon footprint associated with respiratory care. 

John Bell, BMBCh, medical director of BioPharmaceuticals Medical, AstraZeneca, and co-author of the study, said that he was surprised by the scale to which poorly controlled asthma contributed to the overall carbon footprint of asthma care. “This suggests that suboptimal asthma care is not just a public health issue, but also one which has environmental consequences,” he said.

Improving the care of asthma patients could help the NHS meet its net zero target, the authors suggested.
 

SABA – Largest Contributor to Asthma-Related Greenhouse Gases

Healthcare is a major contributor to greenhouse gas emissions. In 2020, the NHS set an ambitious target of reducing its carbon footprint by 80% over the next 15 years, with the aim of reaching net zero by 2045.

To estimate the environmental footprint of asthma care in the UK, the researchers retrospectively analyzed anonymized data of 236,506 people with asthma submitted to the Clinical Practice Research Datalink between 2008 and 2019. 

Greenhouse gas (GHG) emissions, measured as carbon dioxide equivalent (CO2e), were then estimated for asthma-related medication use, healthcare resource utilization, and severe exacerbations.

Well-controlled asthma was considered as having no episodes of severe worsening symptoms and fewer than three prescriptions of short-acting beta-agonists (SABAs) reliever inhalers in a year. Poorly controlled asthma included three or more SABA canister prescriptions or one or more episodes of severe worsening symptoms in a year.

Almost one in two patients with asthma (47.3%) were categorized as being poorly controlled. 

The researchers estimated the overall carbon footprint attributed to asthma care when scaled to the entire UK asthma population was 750,540 tonnes CO2e/year, with poorly controlled asthma contributing to excess GHG emissions of 303,874 tonnes CO2e/year. 

“Poorly controlled asthma generated three-fold higher greenhouse gas emissions per capita compared with well-controlled asthma, when taking into account GHG emissions related to all aspects of asthma care, including routine prescribing and management,” Dr. Bell explained. It also generated eight-fold higher excess per capita carbon footprint compared to well-controlled asthma.

SABA relievers represented the largest contributors to per capita asthma-related GHG emissions, accounting for more than 60% of overall GHG emissions and more than 90% of excess GHG emissions. The remainder was mostly due to healthcare resource utilization, such as GP and hospital visits, required to treat severe worsening symptoms.

The researchers acknowledged various limitations to their findings, including that the study results were largely descriptive in nature. And factors other than the level of asthma symptom control, such as prescribing patterns, may also have contributed to high SABA use.
 

Couple Optimized Patient Outcomes With Environmental Targets

With inappropriate SABA use having emerged as the single largest contributor to asthma care-related GHG emissions, improving this care could achieve substantial carbon emissions savings and help the NHS meet its net zero target, the authors explained. 

This improvement could include the adoption of the Global Initiative for Asthma (GINA) treatment strategies that, since 2019, no longer recommends that SABAs are used alone as the preferred reliever for acute asthma symptoms, the authors wrote. 

However, the National Institute for Health and Care Excellence (NICE) asthma guidelines still recommend SABA alone as a reliever therapy.

On the other hand, the Primary Care Respiratory Society (PCRS) highlights on its website that the Medicines and Healthcare Products Regulatory Agency (MHRA) had approved the use of a dual (inhaled corticosteroid/formoterol) combination treatment to be used as a reliever therapy for people aged 12 and over.

“In the UK, this new therapy option does not yet sit within an approved national guideline as NICE last updated its treatment pathway in 2020. We await a new national asthma guideline but do not anticipate this new joint approach between NICE, BTS [British Thoracic Society], and SIGN [Scottish Intercollegiate Guidelines Network] to publish until 2024,” the society wrote.

Dr. Bell explained that the carbon footprint of asthma care increased with higher socio-economic deprivation. “Thus, targeting suboptimal care to areas of higher deprivation could help improve patient outcomes and address health inequities, with the additional benefit of reducing the overall carbon footprint of asthma care,” he said.

This coupling of optimized patient outcomes with environmental targets to decrease GHG emissions could be extended to other chronic progressive diseases, particularly those associated with multi-morbidities, the authors wrote.

Dr. Andy Whittamore, MBBS, clinical lead at Asthma + Lung UK, who was not involved in the research, said: “This study highlights that high levels of uncontrolled asthma not only put thousands of people at risk of life-threatening asthma attacks, but also have a detrimental effect on the environment. It’s important to point out that people shouldn’t stop taking their inhalers because they are worried about the environment. The best thing for the environment is to keep your asthma under control,” he emphasized.

Please refer to the study for full study author disclosures.Dr. Hicks has disclosed no relevant financial relationships.

A version of this article appeared on Medscape UK.

Soot, or in scientific parlance “fine particulate matter,” isn’t just the stuff that blackens window sills or dulls car finishes — it’s a serious health hazard, linked to cardiopulmonary disease, asthma, allergies, and lung cancer, as well as a host of other harmful conditions.

Until recently, the annual ambient air quality standard established by the US Environmental Protection Agency (EPA) was a maximum of 12 micrograms per cubic meter of air of fine particles smaller than 2.5 microns (PM2.5).

But on February 7, 2024, the EPA announced that the Biden-Harris administration had finalized a new standard of 9 mcg PM2.5/per cubic meter of air.

In addition, the EPA reported that it will be modifying its PM­­2.5 monitoring network to include a factor that will account for the proximity to pollution sources of at-risk populations.

In a press release, the EPA said that the modification “will advance environmental justice by ensuring localized data collection in overburdened areas,” with the goal of informing future National Ambient Air Quality Standards reviews.

In a statement supporting the new standard, Environment America, a network of 30 state environmental groups, noted that in “the United States, the largest human-caused sources of soot pollution are fossil fuels — coal, oil, and gas — burned for electricity and transportation. Since the government last updated its standards, new research has found there may be no safe amount of air pollution and the World Health Organization cut in half its guidelines for allowable particulate matter (soot) pollution. The final rule lowers allowable soot limits for annual exposure by 25%, although it leaves the 24-hour limit unchanged, allowing for temporary pollution spikes.”
 

A Good Start

Pulmonologists interviewed for this article also applauded the tightened PM2.5 standard, but said that the change doesn’t go far enough.

“We know that particulate matter, also called particulate pollution, is the most dangerous form of air pollution, and there has been an extensive body of literature which outlines the negative impact of air pollution and poor air quality not only on respiratory health, but also on cardiovascular disease, premature pregnancies, mental health, and death,” Anne C. Coates, MD, FCCP, a pediatric pulmonologist at MaineHealth in Portland, Maine, said in an interview with this news organization.

“Lowering the limits certainly can help promote overall health as well as reduce asthma, COPD exacerbations, heart attacks, hospitalizations and death,” she said.

However “I wish that the EPA had gone further to address lowering the daily particulate matter standards because, remember, what they issued on February 7th was the reduction in the annual particulate matter,” she noted.

With the tighter standards, “things are going the right way,” said Priya Balakrishnan, MD, MS, FCCP, assistant professor in the Section of Pulmonary and Critical Care Medicine at West Virginia University in Morgantown.

Following Trump administration efforts to weaken regulatory authority and reverse environmental regulations promulgated under President Obama, “this is the first kind of positive legislation moving forward,” she said in an interview with this news organization.

“Obviously, it’s not ideal, because it’s just monitoring the annual particulate matter 2.5 levels rather than daily ones, but it’s still a change in the right direction,” she said.
 

Deadly Air

As Dr. Coates and Dr. Balakrishnan noted, the revised ambient air standard is averaged over a year, and as such may not accurately capture periods where particulate matter concentrations are dangerously high, as occurs in many US states and Canadian provinces during wildfire season, or when one of the more than 200 remaining coal-fired power plants in the US release clouds of soot during daily operations or especially during periods of high electricity demand.

Some pollution sources are worse than others, as shown by a study published in the November 24, 2023, issue of Science. Health and environmental investigators reported that among Medicare beneficiaries, exposure to PM2.5 from sulfur dioxide released by coal burning for electricity generation was associated with a doubling in risk of death compared to PM2.5 exposure from all other sources.

Air pollution has also been identified as a key factor in the development of non–small cell lung cancer in nonsmokers, according to Charles Swanton, PhD, of the Francis Crick Institute, and chief clinician of Cancer Research UK, both in London, and his colleagues.

As Dr. Swanton reported at the 2022 European Society for Medical Oncology Congress, among 447,932 participants in the UK Biobank, increasing exposure to PM2.5 was significantly associated with seven cancer types, including lung cancer. They also saw an association between PM­­2.5 exposure levels and EGFR-mutated lung cancer incidence in the United Kingdom, South Korea, and Taiwan.

And as the investigators showed in mouse models, exposure to PM2.5 of lung cells bearing somatic EGFR and KRAS mutations causes recruitment of macrophages that in turn secrete interleukin-1B, resulting in a transdifferentiation of EGFR-mutated cells into a cancer stem cell state, and tumor formation.
 

Monitoring At-Risk Communities

Lisa Frank, executive director of the Washington legislative office of Environment America, explained in an interview how the revised standards may result in improvements in air quality, especially for at-risk populations such as lower-income urban dwellers.

“Regulations on particulate matter have been around for a few decades now, so there’s an established process that the state agencies and the EPA go through to make sure that air quality standards are met,” she said.

Over the next several years, the EPA will designate areas of the United States as either being in “attainment” (meeting primary or secondary ambient air quality standards) or in “nonattainment.”

“After that, implementation is up to the state and local air boards. They all are required to have a certain number of air quality monitors to keep track of pollution and they also handle reviewing permits for new construction, highways or other projects in that county that might affect air pollution,” she said.

Depending upon their size, counties are required under federal law to have air-quality monitoring sites in areas that are likely to have the worst air quality, such as major highways or urban traffic corridors.

Under the revised regulations, counties will be expected to have air-quality monitoring stations in or near at-risk communities, which should help to mitigate inequities that arise from proximity of polluting power plants in less-advantaged locations, Ms. Frank said.

“I think obviously any improvement in air quality is going to benefit everyone who breathes there, which I hope is all of us, but certainly people who already have the most air pollution hopefully should see bigger gains as well,” she said.

All persons interviewed for this article reported no relevant conflicts of interest. Dr. Coates and Dr. Balakrishnan are members of the editorial advisory board for CHEST Physician.

Soot, or in scientific parlance “fine particulate matter,” isn’t just the stuff that blackens window sills or dulls car finishes — it’s a serious health hazard, linked to cardiopulmonary disease, asthma, allergies, and lung cancer, as well as a host of other harmful conditions.

Until recently, the annual ambient air quality standard established by the US Environmental Protection Agency (EPA) was a maximum of 12 micrograms per cubic meter of air of fine particles smaller than 2.5 microns (PM2.5).

But on February 7, 2024, the EPA announced that the Biden-Harris administration had finalized a new standard of 9 mcg PM2.5/per cubic meter of air.

In addition, the EPA reported that it will be modifying its PM­­2.5 monitoring network to include a factor that will account for the proximity to pollution sources of at-risk populations.

In a press release, the EPA said that the modification “will advance environmental justice by ensuring localized data collection in overburdened areas,” with the goal of informing future National Ambient Air Quality Standards reviews.

In a statement supporting the new standard, Environment America, a network of 30 state environmental groups, noted that in “the United States, the largest human-caused sources of soot pollution are fossil fuels — coal, oil, and gas — burned for electricity and transportation. Since the government last updated its standards, new research has found there may be no safe amount of air pollution and the World Health Organization cut in half its guidelines for allowable particulate matter (soot) pollution. The final rule lowers allowable soot limits for annual exposure by 25%, although it leaves the 24-hour limit unchanged, allowing for temporary pollution spikes.”
 

A Good Start

Pulmonologists interviewed for this article also applauded the tightened PM2.5 standard, but said that the change doesn’t go far enough.

“We know that particulate matter, also called particulate pollution, is the most dangerous form of air pollution, and there has been an extensive body of literature which outlines the negative impact of air pollution and poor air quality not only on respiratory health, but also on cardiovascular disease, premature pregnancies, mental health, and death,” Anne C. Coates, MD, FCCP, a pediatric pulmonologist at MaineHealth in Portland, Maine, said in an interview with this news organization.

“Lowering the limits certainly can help promote overall health as well as reduce asthma, COPD exacerbations, heart attacks, hospitalizations and death,” she said.

However “I wish that the EPA had gone further to address lowering the daily particulate matter standards because, remember, what they issued on February 7th was the reduction in the annual particulate matter,” she noted.

With the tighter standards, “things are going the right way,” said Priya Balakrishnan, MD, MS, FCCP, assistant professor in the Section of Pulmonary and Critical Care Medicine at West Virginia University in Morgantown.

Following Trump administration efforts to weaken regulatory authority and reverse environmental regulations promulgated under President Obama, “this is the first kind of positive legislation moving forward,” she said in an interview with this news organization.

“Obviously, it’s not ideal, because it’s just monitoring the annual particulate matter 2.5 levels rather than daily ones, but it’s still a change in the right direction,” she said.
 

Deadly Air

As Dr. Coates and Dr. Balakrishnan noted, the revised ambient air standard is averaged over a year, and as such may not accurately capture periods where particulate matter concentrations are dangerously high, as occurs in many US states and Canadian provinces during wildfire season, or when one of the more than 200 remaining coal-fired power plants in the US release clouds of soot during daily operations or especially during periods of high electricity demand.

Some pollution sources are worse than others, as shown by a study published in the November 24, 2023, issue of Science. Health and environmental investigators reported that among Medicare beneficiaries, exposure to PM2.5 from sulfur dioxide released by coal burning for electricity generation was associated with a doubling in risk of death compared to PM2.5 exposure from all other sources.

Air pollution has also been identified as a key factor in the development of non–small cell lung cancer in nonsmokers, according to Charles Swanton, PhD, of the Francis Crick Institute, and chief clinician of Cancer Research UK, both in London, and his colleagues.

As Dr. Swanton reported at the 2022 European Society for Medical Oncology Congress, among 447,932 participants in the UK Biobank, increasing exposure to PM2.5 was significantly associated with seven cancer types, including lung cancer. They also saw an association between PM­­2.5 exposure levels and EGFR-mutated lung cancer incidence in the United Kingdom, South Korea, and Taiwan.

And as the investigators showed in mouse models, exposure to PM2.5 of lung cells bearing somatic EGFR and KRAS mutations causes recruitment of macrophages that in turn secrete interleukin-1B, resulting in a transdifferentiation of EGFR-mutated cells into a cancer stem cell state, and tumor formation.
 

Monitoring At-Risk Communities

Lisa Frank, executive director of the Washington legislative office of Environment America, explained in an interview how the revised standards may result in improvements in air quality, especially for at-risk populations such as lower-income urban dwellers.

“Regulations on particulate matter have been around for a few decades now, so there’s an established process that the state agencies and the EPA go through to make sure that air quality standards are met,” she said.

Over the next several years, the EPA will designate areas of the United States as either being in “attainment” (meeting primary or secondary ambient air quality standards) or in “nonattainment.”

“After that, implementation is up to the state and local air boards. They all are required to have a certain number of air quality monitors to keep track of pollution and they also handle reviewing permits for new construction, highways or other projects in that county that might affect air pollution,” she said.

Depending upon their size, counties are required under federal law to have air-quality monitoring sites in areas that are likely to have the worst air quality, such as major highways or urban traffic corridors.

Under the revised regulations, counties will be expected to have air-quality monitoring stations in or near at-risk communities, which should help to mitigate inequities that arise from proximity of polluting power plants in less-advantaged locations, Ms. Frank said.

“I think obviously any improvement in air quality is going to benefit everyone who breathes there, which I hope is all of us, but certainly people who already have the most air pollution hopefully should see bigger gains as well,” she said.

All persons interviewed for this article reported no relevant conflicts of interest. Dr. Coates and Dr. Balakrishnan are members of the editorial advisory board for CHEST Physician.

Soot, or in scientific parlance “fine particulate matter,” isn’t just the stuff that blackens window sills or dulls car finishes — it’s a serious health hazard, linked to cardiopulmonary disease, asthma, allergies, and lung cancer, as well as a host of other harmful conditions.

Until recently, the annual ambient air quality standard established by the US Environmental Protection Agency (EPA) was a maximum of 12 micrograms per cubic meter of air of fine particles smaller than 2.5 microns (PM2.5).

But on February 7, 2024, the EPA announced that the Biden-Harris administration had finalized a new standard of 9 mcg PM2.5/per cubic meter of air.

In addition, the EPA reported that it will be modifying its PM­­2.5 monitoring network to include a factor that will account for the proximity to pollution sources of at-risk populations.

In a press release, the EPA said that the modification “will advance environmental justice by ensuring localized data collection in overburdened areas,” with the goal of informing future National Ambient Air Quality Standards reviews.

In a statement supporting the new standard, Environment America, a network of 30 state environmental groups, noted that in “the United States, the largest human-caused sources of soot pollution are fossil fuels — coal, oil, and gas — burned for electricity and transportation. Since the government last updated its standards, new research has found there may be no safe amount of air pollution and the World Health Organization cut in half its guidelines for allowable particulate matter (soot) pollution. The final rule lowers allowable soot limits for annual exposure by 25%, although it leaves the 24-hour limit unchanged, allowing for temporary pollution spikes.”
 

A Good Start

Pulmonologists interviewed for this article also applauded the tightened PM2.5 standard, but said that the change doesn’t go far enough.

“We know that particulate matter, also called particulate pollution, is the most dangerous form of air pollution, and there has been an extensive body of literature which outlines the negative impact of air pollution and poor air quality not only on respiratory health, but also on cardiovascular disease, premature pregnancies, mental health, and death,” Anne C. Coates, MD, FCCP, a pediatric pulmonologist at MaineHealth in Portland, Maine, said in an interview with this news organization.

“Lowering the limits certainly can help promote overall health as well as reduce asthma, COPD exacerbations, heart attacks, hospitalizations and death,” she said.

However “I wish that the EPA had gone further to address lowering the daily particulate matter standards because, remember, what they issued on February 7th was the reduction in the annual particulate matter,” she noted.

With the tighter standards, “things are going the right way,” said Priya Balakrishnan, MD, MS, FCCP, assistant professor in the Section of Pulmonary and Critical Care Medicine at West Virginia University in Morgantown.

Following Trump administration efforts to weaken regulatory authority and reverse environmental regulations promulgated under President Obama, “this is the first kind of positive legislation moving forward,” she said in an interview with this news organization.

“Obviously, it’s not ideal, because it’s just monitoring the annual particulate matter 2.5 levels rather than daily ones, but it’s still a change in the right direction,” she said.
 

Deadly Air

As Dr. Coates and Dr. Balakrishnan noted, the revised ambient air standard is averaged over a year, and as such may not accurately capture periods where particulate matter concentrations are dangerously high, as occurs in many US states and Canadian provinces during wildfire season, or when one of the more than 200 remaining coal-fired power plants in the US release clouds of soot during daily operations or especially during periods of high electricity demand.

Some pollution sources are worse than others, as shown by a study published in the November 24, 2023, issue of Science. Health and environmental investigators reported that among Medicare beneficiaries, exposure to PM2.5 from sulfur dioxide released by coal burning for electricity generation was associated with a doubling in risk of death compared to PM2.5 exposure from all other sources.

Air pollution has also been identified as a key factor in the development of non–small cell lung cancer in nonsmokers, according to Charles Swanton, PhD, of the Francis Crick Institute, and chief clinician of Cancer Research UK, both in London, and his colleagues.

As Dr. Swanton reported at the 2022 European Society for Medical Oncology Congress, among 447,932 participants in the UK Biobank, increasing exposure to PM2.5 was significantly associated with seven cancer types, including lung cancer. They also saw an association between PM­­2.5 exposure levels and EGFR-mutated lung cancer incidence in the United Kingdom, South Korea, and Taiwan.

And as the investigators showed in mouse models, exposure to PM2.5 of lung cells bearing somatic EGFR and KRAS mutations causes recruitment of macrophages that in turn secrete interleukin-1B, resulting in a transdifferentiation of EGFR-mutated cells into a cancer stem cell state, and tumor formation.
 

Monitoring At-Risk Communities

Lisa Frank, executive director of the Washington legislative office of Environment America, explained in an interview how the revised standards may result in improvements in air quality, especially for at-risk populations such as lower-income urban dwellers.

“Regulations on particulate matter have been around for a few decades now, so there’s an established process that the state agencies and the EPA go through to make sure that air quality standards are met,” she said.

Over the next several years, the EPA will designate areas of the United States as either being in “attainment” (meeting primary or secondary ambient air quality standards) or in “nonattainment.”

“After that, implementation is up to the state and local air boards. They all are required to have a certain number of air quality monitors to keep track of pollution and they also handle reviewing permits for new construction, highways or other projects in that county that might affect air pollution,” she said.

Depending upon their size, counties are required under federal law to have air-quality monitoring sites in areas that are likely to have the worst air quality, such as major highways or urban traffic corridors.

Under the revised regulations, counties will be expected to have air-quality monitoring stations in or near at-risk communities, which should help to mitigate inequities that arise from proximity of polluting power plants in less-advantaged locations, Ms. Frank said.

“I think obviously any improvement in air quality is going to benefit everyone who breathes there, which I hope is all of us, but certainly people who already have the most air pollution hopefully should see bigger gains as well,” she said.

All persons interviewed for this article reported no relevant conflicts of interest. Dr. Coates and Dr. Balakrishnan are members of the editorial advisory board for CHEST Physician.

Airways Disorders Network

Asthma and COPD Section  

Remodeling of airways and destruction of parenchyma by immune and inflammatory mechanisms are the leading cause of lung function decline in patients with COPD. Type 2 inflammation has been recognized as an important phenotypic pathway in asthma. However, its role in COPD has been much less clear, which had been largely associated with innate immune response.¹

Activation of Interleukin (IL)-25, IL-33, thymic stromal lymphopoietin (TSLP) produces type 2 cytokines IL-4, IL-5, and IL-13, either by binding to ILC2 or by direct Th2 cells resulting in elevated eosinophils in sputum, lungs, and blood, as well as fractional exhaled nitric oxide.² The combined inflammation from this pathway underpins the pathological changes seen in airway mucosa, causing mucous hypersecretion and hyperresponsiveness.

Prior trials delineating the role of biologics, such as mepolizumab and benralizumab, showed variable results with possible benefit of add-on biologics on the annual COPD exacerbations among patients with eosinophilic phenotype of COPD.³

More recently, the BOREAS trial evaluated the role of dupilumab as an add-on therapy for patients with type 2 inflammation-driven COPD established using blood eosinophil count of at least 300/mL at initial screening.⁴ Dupilumab is a human monoclonal antibody that blocks combined IL-4 and IL-13 pathways with a broader effect on the type 2 inflammation. It included patients with moderate to severe exacerbations despite maximal triple inhaler therapy with blood eosinophilia. Patients with asthma were excluded. This 52-week trial showed reduction in annual moderate to severe COPD exacerbations, sustained lung function improvement as measured by prebronchodilator FEV₁, and improvement in patient-reported respiratory symptoms.⁴ Evaluation of sustainability of these results with therapy step-down approaches should be explored.

References

1. Scanlon & McKenzie, 2012.

2. Brusselle et al, 2013.

3. Pavord et al, 2017.

4. Bhatt et al, 2023.

Airways Disorders Network

Asthma and COPD Section  

Remodeling of airways and destruction of parenchyma by immune and inflammatory mechanisms are the leading cause of lung function decline in patients with COPD. Type 2 inflammation has been recognized as an important phenotypic pathway in asthma. However, its role in COPD has been much less clear, which had been largely associated with innate immune response.¹

Activation of Interleukin (IL)-25, IL-33, thymic stromal lymphopoietin (TSLP) produces type 2 cytokines IL-4, IL-5, and IL-13, either by binding to ILC2 or by direct Th2 cells resulting in elevated eosinophils in sputum, lungs, and blood, as well as fractional exhaled nitric oxide.² The combined inflammation from this pathway underpins the pathological changes seen in airway mucosa, causing mucous hypersecretion and hyperresponsiveness.

Prior trials delineating the role of biologics, such as mepolizumab and benralizumab, showed variable results with possible benefit of add-on biologics on the annual COPD exacerbations among patients with eosinophilic phenotype of COPD.³

More recently, the BOREAS trial evaluated the role of dupilumab as an add-on therapy for patients with type 2 inflammation-driven COPD established using blood eosinophil count of at least 300/mL at initial screening.⁴ Dupilumab is a human monoclonal antibody that blocks combined IL-4 and IL-13 pathways with a broader effect on the type 2 inflammation. It included patients with moderate to severe exacerbations despite maximal triple inhaler therapy with blood eosinophilia. Patients with asthma were excluded. This 52-week trial showed reduction in annual moderate to severe COPD exacerbations, sustained lung function improvement as measured by prebronchodilator FEV₁, and improvement in patient-reported respiratory symptoms.⁴ Evaluation of sustainability of these results with therapy step-down approaches should be explored.

References

1. Scanlon & McKenzie, 2012.

2. Brusselle et al, 2013.

3. Pavord et al, 2017.

4. Bhatt et al, 2023.

Airways Disorders Network

Asthma and COPD Section  

Remodeling of airways and destruction of parenchyma by immune and inflammatory mechanisms are the leading cause of lung function decline in patients with COPD. Type 2 inflammation has been recognized as an important phenotypic pathway in asthma. However, its role in COPD has been much less clear, which had been largely associated with innate immune response.¹

Activation of Interleukin (IL)-25, IL-33, thymic stromal lymphopoietin (TSLP) produces type 2 cytokines IL-4, IL-5, and IL-13, either by binding to ILC2 or by direct Th2 cells resulting in elevated eosinophils in sputum, lungs, and blood, as well as fractional exhaled nitric oxide.² The combined inflammation from this pathway underpins the pathological changes seen in airway mucosa, causing mucous hypersecretion and hyperresponsiveness.

Prior trials delineating the role of biologics, such as mepolizumab and benralizumab, showed variable results with possible benefit of add-on biologics on the annual COPD exacerbations among patients with eosinophilic phenotype of COPD.³

More recently, the BOREAS trial evaluated the role of dupilumab as an add-on therapy for patients with type 2 inflammation-driven COPD established using blood eosinophil count of at least 300/mL at initial screening.⁴ Dupilumab is a human monoclonal antibody that blocks combined IL-4 and IL-13 pathways with a broader effect on the type 2 inflammation. It included patients with moderate to severe exacerbations despite maximal triple inhaler therapy with blood eosinophilia. Patients with asthma were excluded. This 52-week trial showed reduction in annual moderate to severe COPD exacerbations, sustained lung function improvement as measured by prebronchodilator FEV₁, and improvement in patient-reported respiratory symptoms.⁴ Evaluation of sustainability of these results with therapy step-down approaches should be explored.

References

1. Scanlon & McKenzie, 2012.

2. Brusselle et al, 2013.

3. Pavord et al, 2017.

4. Bhatt et al, 2023.

The MightySat Medical, an over-the-counter medical fingertip pulse oximeter, has received clearance from the US Food and Drug Administration (FDA) for use without a prescription, according to a press release from manufacturer Masimo.

The device is the first medical fingertip pulse oximeter available directly to consumers without a prescription that includes the same technology used by many hospitals, according to the company.

According to the FDA, home pulse oximeters are currently generally of two classes: hospital-grade prescription devices which have been vetted for accuracy through clinical trials, and over-the-counter devices which are sold direct to consumers but often estimate oxygen saturation. FDA communication on pulse oximeter accuracy states "OTC oximeters that are sold as either general wellness or sporting/aviation products are not intended for medical purposes, so they do not undergo FDA review."

Pulse oximeter use is important for patients diagnosed with breathing problems or lung diseases such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer, flu, pneumonia, or COVID-19 to collect accurate data on arterial blood oxygen saturation that they can share with their healthcare providers, according to the company. Patients with cardiac conditions, including pulmonary hypertension and heart failure may also benefit from pulse oximeter monitoring.

However, challenges of pulse oximeter use include measuring accuracy when patients are moving, measuring patients with poor circulation, and measuring patients with cool, thick, or darker skin. The MightySat Medical is designed to provide reliable measures of oxygen saturation and pulse rate across all patient groups, the manufacturers wrote in the press release.

Asked for additional comment, Diego J. Maselli, MD, FCCP, Professor and Chief in the division of Pulmonary Diseases and Critical Care at UT Health at San Antonio, noted, "Over the past decades, there has been an increased interest in home monitoring of medical conditions, particulrly with the development of more portable and accessible technology."

"This was heightended by the COVID-19 pandemic where telemedicine was frequently required as a means of delivering care," Dr. Maselli continued. "One of the important characteristics to monitor was the oxgen saturation in patients that had an active COVID-19 infection as it would dictate management and was part of the protocol for monitoring the clinical course of infection. Because of this need, many companies developed portable pulse oximeters for home use. This resulted in widespread use of pulse oximeters at home and other places outside clinic or hospital."

Other over-the-counter pulse oximeters that are not cleared by the FDA may create confusion among patients about the accuracy of their measurements, according to the company.

Dr. Maselli also commented that pulse oximeters' value can vary. "Unfortunately, these devices vary in quality and reliability and patients may not be fully aware of this. Most recently, the FDA approved a hospital-grade pulse oximeter that requires no prescription. This device may provide a more accurate reading in a wide range of clinical situations outside the healthcare setting. Patients should be aware that there are different grades of pulse oximeter before selecting one for home use. In addition, patients should work closely with their providers to better select the monitoring modaility that best fits their clinical situation," he said.

MightySat Medical is indicated for individuals aged 18 years and older who are well or poorly perfused under no motion conditions and is not intended as a diagnostic or screening tool for lung disease, according to the release. Treatment decisions based on data from the device should be made only in consultation with a healthcare provider, the company said. Dr. Maselli serves as a member of the CHEST Physician editorial board.

The FDA’s website offers further guidance related to at-home pulse oximeter use, with recommendations and limitations, as well as information on initiatives to ensure accurate and equitable pulse oximetry for all patients.

A version of this article appeared on Medscape.com.

The MightySat Medical, an over-the-counter medical fingertip pulse oximeter, has received clearance from the US Food and Drug Administration (FDA) for use without a prescription, according to a press release from manufacturer Masimo.

The device is the first medical fingertip pulse oximeter available directly to consumers without a prescription that includes the same technology used by many hospitals, according to the company.

According to the FDA, home pulse oximeters are currently generally of two classes: hospital-grade prescription devices which have been vetted for accuracy through clinical trials, and over-the-counter devices which are sold direct to consumers but often estimate oxygen saturation. FDA communication on pulse oximeter accuracy states "OTC oximeters that are sold as either general wellness or sporting/aviation products are not intended for medical purposes, so they do not undergo FDA review."

Pulse oximeter use is important for patients diagnosed with breathing problems or lung diseases such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer, flu, pneumonia, or COVID-19 to collect accurate data on arterial blood oxygen saturation that they can share with their healthcare providers, according to the company. Patients with cardiac conditions, including pulmonary hypertension and heart failure may also benefit from pulse oximeter monitoring.

However, challenges of pulse oximeter use include measuring accuracy when patients are moving, measuring patients with poor circulation, and measuring patients with cool, thick, or darker skin. The MightySat Medical is designed to provide reliable measures of oxygen saturation and pulse rate across all patient groups, the manufacturers wrote in the press release.

Asked for additional comment, Diego J. Maselli, MD, FCCP, Professor and Chief in the division of Pulmonary Diseases and Critical Care at UT Health at San Antonio, noted, "Over the past decades, there has been an increased interest in home monitoring of medical conditions, particulrly with the development of more portable and accessible technology."

"This was heightended by the COVID-19 pandemic where telemedicine was frequently required as a means of delivering care," Dr. Maselli continued. "One of the important characteristics to monitor was the oxgen saturation in patients that had an active COVID-19 infection as it would dictate management and was part of the protocol for monitoring the clinical course of infection. Because of this need, many companies developed portable pulse oximeters for home use. This resulted in widespread use of pulse oximeters at home and other places outside clinic or hospital."

Other over-the-counter pulse oximeters that are not cleared by the FDA may create confusion among patients about the accuracy of their measurements, according to the company.

Dr. Maselli also commented that pulse oximeters' value can vary. "Unfortunately, these devices vary in quality and reliability and patients may not be fully aware of this. Most recently, the FDA approved a hospital-grade pulse oximeter that requires no prescription. This device may provide a more accurate reading in a wide range of clinical situations outside the healthcare setting. Patients should be aware that there are different grades of pulse oximeter before selecting one for home use. In addition, patients should work closely with their providers to better select the monitoring modaility that best fits their clinical situation," he said.

MightySat Medical is indicated for individuals aged 18 years and older who are well or poorly perfused under no motion conditions and is not intended as a diagnostic or screening tool for lung disease, according to the release. Treatment decisions based on data from the device should be made only in consultation with a healthcare provider, the company said. Dr. Maselli serves as a member of the CHEST Physician editorial board.

The FDA’s website offers further guidance related to at-home pulse oximeter use, with recommendations and limitations, as well as information on initiatives to ensure accurate and equitable pulse oximetry for all patients.

A version of this article appeared on Medscape.com.

The MightySat Medical, an over-the-counter medical fingertip pulse oximeter, has received clearance from the US Food and Drug Administration (FDA) for use without a prescription, according to a press release from manufacturer Masimo.

The device is the first medical fingertip pulse oximeter available directly to consumers without a prescription that includes the same technology used by many hospitals, according to the company.

According to the FDA, home pulse oximeters are currently generally of two classes: hospital-grade prescription devices which have been vetted for accuracy through clinical trials, and over-the-counter devices which are sold direct to consumers but often estimate oxygen saturation. FDA communication on pulse oximeter accuracy states "OTC oximeters that are sold as either general wellness or sporting/aviation products are not intended for medical purposes, so they do not undergo FDA review."

Pulse oximeter use is important for patients diagnosed with breathing problems or lung diseases such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer, flu, pneumonia, or COVID-19 to collect accurate data on arterial blood oxygen saturation that they can share with their healthcare providers, according to the company. Patients with cardiac conditions, including pulmonary hypertension and heart failure may also benefit from pulse oximeter monitoring.

However, challenges of pulse oximeter use include measuring accuracy when patients are moving, measuring patients with poor circulation, and measuring patients with cool, thick, or darker skin. The MightySat Medical is designed to provide reliable measures of oxygen saturation and pulse rate across all patient groups, the manufacturers wrote in the press release.

Asked for additional comment, Diego J. Maselli, MD, FCCP, Professor and Chief in the division of Pulmonary Diseases and Critical Care at UT Health at San Antonio, noted, "Over the past decades, there has been an increased interest in home monitoring of medical conditions, particulrly with the development of more portable and accessible technology."

"This was heightended by the COVID-19 pandemic where telemedicine was frequently required as a means of delivering care," Dr. Maselli continued. "One of the important characteristics to monitor was the oxgen saturation in patients that had an active COVID-19 infection as it would dictate management and was part of the protocol for monitoring the clinical course of infection. Because of this need, many companies developed portable pulse oximeters for home use. This resulted in widespread use of pulse oximeters at home and other places outside clinic or hospital."

Other over-the-counter pulse oximeters that are not cleared by the FDA may create confusion among patients about the accuracy of their measurements, according to the company.

Dr. Maselli also commented that pulse oximeters' value can vary. "Unfortunately, these devices vary in quality and reliability and patients may not be fully aware of this. Most recently, the FDA approved a hospital-grade pulse oximeter that requires no prescription. This device may provide a more accurate reading in a wide range of clinical situations outside the healthcare setting. Patients should be aware that there are different grades of pulse oximeter before selecting one for home use. In addition, patients should work closely with their providers to better select the monitoring modaility that best fits their clinical situation," he said.

MightySat Medical is indicated for individuals aged 18 years and older who are well or poorly perfused under no motion conditions and is not intended as a diagnostic or screening tool for lung disease, according to the release. Treatment decisions based on data from the device should be made only in consultation with a healthcare provider, the company said. Dr. Maselli serves as a member of the CHEST Physician editorial board.

The FDA’s website offers further guidance related to at-home pulse oximeter use, with recommendations and limitations, as well as information on initiatives to ensure accurate and equitable pulse oximetry for all patients.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved omalizumab (Xolair, Genentech) for reducing allergic reactions to foods in adults and most children. The drug is meant to be taken regularly by patients with food allergies to reduce the risk for reactions, including anaphylaxis, in case of accidental exposure to one or more allergens. The injection is not approved for emergency treatment of an allergic reaction.

Omalizumab first was approved for persistent allergic asthma in 2003. It also is approved for chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps. 

The new indication for immunoglobulin E–mediated food allergy in adults and children aged 1 year or older makes omalizumab the first drug approved to mitigate allergic reactions to more than one food, the FDA said. Peanut-allergen powder (Palforzia) can reduce reactions to peanut, but its benefits are limited to that allergy.

“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” said Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, in a news release. 

The safety and efficacy of the monoclonal antibody in reducing allergic reactions was studied in a double-blind, placebo-controlled study of 168 children and adults who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. Patients received omalizumab or placebo for 16-20 weeks. At the end of the study, patients consumed peanut protein (equivalent to 2.5 peanuts). Of those who received the drug, 68% were able to consume peanut without moderate or severe allergic symptoms, versus 6% in the placebo group.

More patients who received the medication also avoided moderate or severe reactions to cashews (42% vs 3%), milk (66% vs 11%), and eggs (67% vs 0%). 

The most common side effects of omalizumab included injection site reactions and fever. The drug’s label includes warnings and precautions about anaphylaxis, cancer, fever, joint pain, rash, parasitic (worm) infection, and abnormal laboratory tests. Omalizumab comes with a boxed warning for anaphylaxis and should be started only in a healthcare setting equipped to manage anaphylaxis, according to the FDA.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved omalizumab (Xolair, Genentech) for reducing allergic reactions to foods in adults and most children. The drug is meant to be taken regularly by patients with food allergies to reduce the risk for reactions, including anaphylaxis, in case of accidental exposure to one or more allergens. The injection is not approved for emergency treatment of an allergic reaction.

Omalizumab first was approved for persistent allergic asthma in 2003. It also is approved for chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps. 

The new indication for immunoglobulin E–mediated food allergy in adults and children aged 1 year or older makes omalizumab the first drug approved to mitigate allergic reactions to more than one food, the FDA said. Peanut-allergen powder (Palforzia) can reduce reactions to peanut, but its benefits are limited to that allergy.

“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” said Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, in a news release. 

The safety and efficacy of the monoclonal antibody in reducing allergic reactions was studied in a double-blind, placebo-controlled study of 168 children and adults who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. Patients received omalizumab or placebo for 16-20 weeks. At the end of the study, patients consumed peanut protein (equivalent to 2.5 peanuts). Of those who received the drug, 68% were able to consume peanut without moderate or severe allergic symptoms, versus 6% in the placebo group.

More patients who received the medication also avoided moderate or severe reactions to cashews (42% vs 3%), milk (66% vs 11%), and eggs (67% vs 0%). 

The most common side effects of omalizumab included injection site reactions and fever. The drug’s label includes warnings and precautions about anaphylaxis, cancer, fever, joint pain, rash, parasitic (worm) infection, and abnormal laboratory tests. Omalizumab comes with a boxed warning for anaphylaxis and should be started only in a healthcare setting equipped to manage anaphylaxis, according to the FDA.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved omalizumab (Xolair, Genentech) for reducing allergic reactions to foods in adults and most children. The drug is meant to be taken regularly by patients with food allergies to reduce the risk for reactions, including anaphylaxis, in case of accidental exposure to one or more allergens. The injection is not approved for emergency treatment of an allergic reaction.

Omalizumab first was approved for persistent allergic asthma in 2003. It also is approved for chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps. 

The new indication for immunoglobulin E–mediated food allergy in adults and children aged 1 year or older makes omalizumab the first drug approved to mitigate allergic reactions to more than one food, the FDA said. Peanut-allergen powder (Palforzia) can reduce reactions to peanut, but its benefits are limited to that allergy.

“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” said Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, in a news release. 

The safety and efficacy of the monoclonal antibody in reducing allergic reactions was studied in a double-blind, placebo-controlled study of 168 children and adults who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. Patients received omalizumab or placebo for 16-20 weeks. At the end of the study, patients consumed peanut protein (equivalent to 2.5 peanuts). Of those who received the drug, 68% were able to consume peanut without moderate or severe allergic symptoms, versus 6% in the placebo group.

More patients who received the medication also avoided moderate or severe reactions to cashews (42% vs 3%), milk (66% vs 11%), and eggs (67% vs 0%). 

The most common side effects of omalizumab included injection site reactions and fever. The drug’s label includes warnings and precautions about anaphylaxis, cancer, fever, joint pain, rash, parasitic (worm) infection, and abnormal laboratory tests. Omalizumab comes with a boxed warning for anaphylaxis and should be started only in a healthcare setting equipped to manage anaphylaxis, according to the FDA.

A version of this article appeared on Medscape.com.

TOPLINE:

Individuals with either high or low body mass index (BMI) showed an increased risk for respiratory symptoms and diseases than those with BMI in the normal range.

METHODOLOGY:

• The researchers reviewed data from the National Health and Nutrition Examination Survey (NHANES) from 2003 to 2012; the study population included 12,719 adults older than 40 years with data on respiratory symptoms; 51% were female, and 53.3% were non-Hispanic White individuals.
• The study population was divided into quartiles based on BMI as follows: 3180 individuals with BMI of 13.2-24.9 kg/m², 3175 with BMI of 24.9-28.4 kg/m², 3180 with BMI of 28.4-32.5 kg/m², and 3184 with BMI of 32.5-82.0 kg/m².
• The study sought to assess the correlation between BMI and respiratory symptoms (cough, wheezing, and dyspnea), chronic obstructive pulmonary disease (COPD), and asthma in unadjusted and adjusted models based on sex, race, marital status, poverty-income ratio (PIR), education level, and smoking status.

TAKEAWAY:

• In a logistic regression and curve fitting analysis, BMI showed a U-shaped relationship with respiratory symptoms, asthma, and COPD, with increased risk in individuals with high or low BMI than those with BMIs in the middle quartiles.
• In a stratified analysis by race, the risk for cough was significantly higher among non-Hispanic Black individuals than other races (P < .0001), and a higher BMI was associated with an increased risk for COPD in non-Hispanic Black individuals (odds ratio, 1.053; P < .0001).
• The researchers found no significant impact of biological sex on the relationship between BMI and respiratory symptoms, COPD, or asthma.
• The results support previous studies showing that a BMI that is too low can be detrimental to health.

IN PRACTICE:

“These results suggest that the risk of small airway obstruction in underweight individuals deserves more attention and that excessive wasting may also affect the prognosis of patients with COPD,” the researchers wrote. 

SOURCE:

The lead author on the study was Yuefeng Sun of Shandong University of Traditional Chinese Medicine, Jinan, China. The study was published online on January 10, 2024, in Scientific Reports. 

LIMITATIONS:

The cross-sectional NHANES database prevented conclusions of causality, and potential confounding factors that were not accounted for could have affected the results.

DISCLOSURES:

The study was supported by the Shandong Province Taishan Scholar Project. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Individuals with either high or low body mass index (BMI) showed an increased risk for respiratory symptoms and diseases than those with BMI in the normal range.

METHODOLOGY:

• The researchers reviewed data from the National Health and Nutrition Examination Survey (NHANES) from 2003 to 2012; the study population included 12,719 adults older than 40 years with data on respiratory symptoms; 51% were female, and 53.3% were non-Hispanic White individuals.
• The study population was divided into quartiles based on BMI as follows: 3180 individuals with BMI of 13.2-24.9 kg/m², 3175 with BMI of 24.9-28.4 kg/m², 3180 with BMI of 28.4-32.5 kg/m², and 3184 with BMI of 32.5-82.0 kg/m².
• The study sought to assess the correlation between BMI and respiratory symptoms (cough, wheezing, and dyspnea), chronic obstructive pulmonary disease (COPD), and asthma in unadjusted and adjusted models based on sex, race, marital status, poverty-income ratio (PIR), education level, and smoking status.

TAKEAWAY:

• In a logistic regression and curve fitting analysis, BMI showed a U-shaped relationship with respiratory symptoms, asthma, and COPD, with increased risk in individuals with high or low BMI than those with BMIs in the middle quartiles.
• In a stratified analysis by race, the risk for cough was significantly higher among non-Hispanic Black individuals than other races (P < .0001), and a higher BMI was associated with an increased risk for COPD in non-Hispanic Black individuals (odds ratio, 1.053; P < .0001).
• The researchers found no significant impact of biological sex on the relationship between BMI and respiratory symptoms, COPD, or asthma.
• The results support previous studies showing that a BMI that is too low can be detrimental to health.

IN PRACTICE:

“These results suggest that the risk of small airway obstruction in underweight individuals deserves more attention and that excessive wasting may also affect the prognosis of patients with COPD,” the researchers wrote. 

SOURCE:

The lead author on the study was Yuefeng Sun of Shandong University of Traditional Chinese Medicine, Jinan, China. The study was published online on January 10, 2024, in Scientific Reports. 

LIMITATIONS:

The cross-sectional NHANES database prevented conclusions of causality, and potential confounding factors that were not accounted for could have affected the results.

DISCLOSURES:

The study was supported by the Shandong Province Taishan Scholar Project. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Individuals with either high or low body mass index (BMI) showed an increased risk for respiratory symptoms and diseases than those with BMI in the normal range.

METHODOLOGY:

• The researchers reviewed data from the National Health and Nutrition Examination Survey (NHANES) from 2003 to 2012; the study population included 12,719 adults older than 40 years with data on respiratory symptoms; 51% were female, and 53.3% were non-Hispanic White individuals.
• The study population was divided into quartiles based on BMI as follows: 3180 individuals with BMI of 13.2-24.9 kg/m², 3175 with BMI of 24.9-28.4 kg/m², 3180 with BMI of 28.4-32.5 kg/m², and 3184 with BMI of 32.5-82.0 kg/m².
• The study sought to assess the correlation between BMI and respiratory symptoms (cough, wheezing, and dyspnea), chronic obstructive pulmonary disease (COPD), and asthma in unadjusted and adjusted models based on sex, race, marital status, poverty-income ratio (PIR), education level, and smoking status.

TAKEAWAY:

• In a logistic regression and curve fitting analysis, BMI showed a U-shaped relationship with respiratory symptoms, asthma, and COPD, with increased risk in individuals with high or low BMI than those with BMIs in the middle quartiles.
• In a stratified analysis by race, the risk for cough was significantly higher among non-Hispanic Black individuals than other races (P < .0001), and a higher BMI was associated with an increased risk for COPD in non-Hispanic Black individuals (odds ratio, 1.053; P < .0001).
• The researchers found no significant impact of biological sex on the relationship between BMI and respiratory symptoms, COPD, or asthma.
• The results support previous studies showing that a BMI that is too low can be detrimental to health.

IN PRACTICE:

“These results suggest that the risk of small airway obstruction in underweight individuals deserves more attention and that excessive wasting may also affect the prognosis of patients with COPD,” the researchers wrote. 

SOURCE:

The lead author on the study was Yuefeng Sun of Shandong University of Traditional Chinese Medicine, Jinan, China. The study was published online on January 10, 2024, in Scientific Reports. 

LIMITATIONS:

The cross-sectional NHANES database prevented conclusions of causality, and potential confounding factors that were not accounted for could have affected the results.

DISCLOSURES:

The study was supported by the Shandong Province Taishan Scholar Project. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

A recent alert posted on the Asthma and Allergy Foundation of America (AAFA) website blog announced, “Flovent HFA and Flovent Diskus Asthma Medicine Being Discontinued.” A further heading positioned next to images of the two red inhaler devices stated: “Generic versions of the same medicines and devices are available but you need to check your insurance.” While few, it is generally thought, will have trouble finding suitable alternatives, the warning captured the reality descending upon some individual asthma sufferers whose insurance coverage may need tweaking at the very least, or at worst may be lacking.

The AAFA blog included a GSK (GlaxoSmithKline) November 2023 statement to AAFA regarding the brand name FLOVENT discontinuation. It noted the launch of an authorized Flovent HFA (fluticasone propionate inhalation aerosol) generic in May 2022 and a planned (October 2023) launch of an authorized generic for Flovent Diskus (fluticasone propionate inhalation powder) as “part of our commitment to be ambitious for patients.” The GSK statement continues: “These GSK manufactured authorized generics will provide patients in the US with potentially lower cost alternatives of these medically important products. We recognize that patients have a number of options in the therapeutic area and therefore remain committed to ensuring the affordability of our medicines.”

GSK will continue to manufacture the authorized generics, but they will be distributed by Prasco LLC.
 

Medicaid Rebate Cap Removed

As a Forbes article on January 3, 2024, by Joshua Cohen (“New Medicaid Rebate Rule Causes Problems For Asthma Patients On Flovent”) points out, the Flovent January 1, 2024, discontinuation coincided with the removal of the Medicaid rebate cap (American Rescue Plan Medicaid Drug Rebate Program) targeting manufacturers who had previously raised medication prices at rates higher than the inflation rate. The Forbes story notes GoodRx data showing a 47% increase in Flovent price since 2014. The implication is that drug manufacturers could be forced to sell such a drug to Medicaid at a loss because of the rebate cap removal. An authorized generic introduced to the market at a lower price under a private label with no price history, however, would not be subject to the higher Medicaid rebates.

Motivation considerations aside, the fallout for patients may or may not include a lower cost alternative. The authorized generic versions of Flovent HFA and Flovent Diskus are identical to the branded products with respect to the drugs and the devices. The GSK statement expressed hope that most insurance plans will replace the brand name with the authorized generic. The possibility persists, however, that there may be some that do not — resulting in a need to find the right substitute and/or higher out-of-pocket costs.

“Even though some patients may experience some disruption initially in their prescriptions,” Diego J. Maselli, MD, professor and chief, division of pulmonary diseases and critical care, UT Health at San Antonio, Texas, said in an interview, “fortunately, there are quite a few alternatives, and we don’t anticipate significant problems. It will be a wrinkle for some of the patients with regard to coverage, but there are definitely many alternatives that can provide good enough treatment for them.”
 

Similar alternative inhalers?

The alternatives have their specific properties and qualities, but the vast majority of experts, Dr. Maselli said, consider them to be very similar.

For CAREMARK CVS, a major pharmaceutical benefits manager, the preferred Flovent substitute is Pulmicort Flexhaler, a dry-powder inhaler that contains budesonide rather than fluticasone. While Flovent HF is a metered dose inhaler with a propellant, the Pulmicort device contains budesonide as a dry powder and requires activation through inhalation, which can be problematic for young children, AAFA CEO Kenneth Mendez said in an interview. To address that issue, he said, CVS Caremark is covering the authorized fluticasone metered dose inhaler generic for children under 6 years old. “Those individuals 6 years and older with severe asthma who can’t breathe deeply enough to get the medicine into their lungs will have to work with their doctors to apply for a formulary exception. And that’s a complicated process,” Mr. Mendez observed. “And it can take some time,” he added.

Another key issue highlighted here, he emphasized, is “how complicated this system is.” The U.S. drug pricing ecosystem involves multiple manufacturers, pharmacy benefit managers, insurance companies and their various plans, and federal policies potentially creating situations that may reduce access to critical medicines for patients, Mr. Mendez said. “Some people will be scurrying and scrambling to try to get coverage. The scope of the impact is actually unknown, but we’re going to find out now. As a nonprofit, we monitor social media and we’re listening closely.”

AAFA’s further concern is the rising costs of asthma medications. “It’s the number one thing we hear about as a patient organization,” Mr. Mendez said. On January 9, 2024, AAFA issued a press release praising the previous day’s news item from the U.S. Senate Committee on Health, Education, Labor & Pensions (“Chairman Sanders, Baldwin, Luján, Markey Launch HELP Committee Investigation into Efforts by Pharmaceutical Companies to Manipulate the Price of Asthma Inhalers). In it, Senator Bernie Sanders pointed to the more than 12-fold higher cost in the United States compared with the United Kingdom for GSK’s inhaler combining fluticasone and a beta2 agonist. The Senate HELP Committee has sent letters to the CEOs of the four major inhaler manufacturers (AstraZeneca, Boehringer Ingelheim, GSK, and Teva), stating: “These prices force patients, especially the uninsured and underinsured, to ration doses or abandon their prescriptions altogether. The results are predictable and devastating.”
 

High costs of inhalers could lead to rationing

AAFA research, the AAFA press release states, confirms that when asthma medicine costs become a barrier to treatment, people with asthma ration or discontinue medication use. The release also includes Mr. Mendez’s plea for a broad national conversation. “We are hopeful the HELP Committee investigation will lead to a national conversation about asthma drug costs and produce action that breaks down barriers to affordable treatment for people with asthma. The bottom line is that cost drives access. We understand the barriers, now it is important to move toward solutions.”

AAFA’s blog advises that when an individual’s insurance plan does not cover the authorized generic and does not offer a formulary exception, other inhaler options include ArmonAir Digihaler and Arnuity Ellipta. Because these are not identical to the authorized generics, individuals should check with their doctors regarding available doses and inhaler types and, if necessary, request training on inhaler use.

“It is really important for people with asthma to continue their asthma control medicines, especially during respiratory illness season.” AAFA urges individuals with asthma who are currently Flovent users to check with their doctors or pharmacists about the best next steps for them.

A recent alert posted on the Asthma and Allergy Foundation of America (AAFA) website blog announced, “Flovent HFA and Flovent Diskus Asthma Medicine Being Discontinued.” A further heading positioned next to images of the two red inhaler devices stated: “Generic versions of the same medicines and devices are available but you need to check your insurance.” While few, it is generally thought, will have trouble finding suitable alternatives, the warning captured the reality descending upon some individual asthma sufferers whose insurance coverage may need tweaking at the very least, or at worst may be lacking.

The AAFA blog included a GSK (GlaxoSmithKline) November 2023 statement to AAFA regarding the brand name FLOVENT discontinuation. It noted the launch of an authorized Flovent HFA (fluticasone propionate inhalation aerosol) generic in May 2022 and a planned (October 2023) launch of an authorized generic for Flovent Diskus (fluticasone propionate inhalation powder) as “part of our commitment to be ambitious for patients.” The GSK statement continues: “These GSK manufactured authorized generics will provide patients in the US with potentially lower cost alternatives of these medically important products. We recognize that patients have a number of options in the therapeutic area and therefore remain committed to ensuring the affordability of our medicines.”

GSK will continue to manufacture the authorized generics, but they will be distributed by Prasco LLC.
 

Medicaid Rebate Cap Removed

As a Forbes article on January 3, 2024, by Joshua Cohen (“New Medicaid Rebate Rule Causes Problems For Asthma Patients On Flovent”) points out, the Flovent January 1, 2024, discontinuation coincided with the removal of the Medicaid rebate cap (American Rescue Plan Medicaid Drug Rebate Program) targeting manufacturers who had previously raised medication prices at rates higher than the inflation rate. The Forbes story notes GoodRx data showing a 47% increase in Flovent price since 2014. The implication is that drug manufacturers could be forced to sell such a drug to Medicaid at a loss because of the rebate cap removal. An authorized generic introduced to the market at a lower price under a private label with no price history, however, would not be subject to the higher Medicaid rebates.

Motivation considerations aside, the fallout for patients may or may not include a lower cost alternative. The authorized generic versions of Flovent HFA and Flovent Diskus are identical to the branded products with respect to the drugs and the devices. The GSK statement expressed hope that most insurance plans will replace the brand name with the authorized generic. The possibility persists, however, that there may be some that do not — resulting in a need to find the right substitute and/or higher out-of-pocket costs.

“Even though some patients may experience some disruption initially in their prescriptions,” Diego J. Maselli, MD, professor and chief, division of pulmonary diseases and critical care, UT Health at San Antonio, Texas, said in an interview, “fortunately, there are quite a few alternatives, and we don’t anticipate significant problems. It will be a wrinkle for some of the patients with regard to coverage, but there are definitely many alternatives that can provide good enough treatment for them.”
 

Similar alternative inhalers?

The alternatives have their specific properties and qualities, but the vast majority of experts, Dr. Maselli said, consider them to be very similar.

For CAREMARK CVS, a major pharmaceutical benefits manager, the preferred Flovent substitute is Pulmicort Flexhaler, a dry-powder inhaler that contains budesonide rather than fluticasone. While Flovent HF is a metered dose inhaler with a propellant, the Pulmicort device contains budesonide as a dry powder and requires activation through inhalation, which can be problematic for young children, AAFA CEO Kenneth Mendez said in an interview. To address that issue, he said, CVS Caremark is covering the authorized fluticasone metered dose inhaler generic for children under 6 years old. “Those individuals 6 years and older with severe asthma who can’t breathe deeply enough to get the medicine into their lungs will have to work with their doctors to apply for a formulary exception. And that’s a complicated process,” Mr. Mendez observed. “And it can take some time,” he added.

Another key issue highlighted here, he emphasized, is “how complicated this system is.” The U.S. drug pricing ecosystem involves multiple manufacturers, pharmacy benefit managers, insurance companies and their various plans, and federal policies potentially creating situations that may reduce access to critical medicines for patients, Mr. Mendez said. “Some people will be scurrying and scrambling to try to get coverage. The scope of the impact is actually unknown, but we’re going to find out now. As a nonprofit, we monitor social media and we’re listening closely.”

AAFA’s further concern is the rising costs of asthma medications. “It’s the number one thing we hear about as a patient organization,” Mr. Mendez said. On January 9, 2024, AAFA issued a press release praising the previous day’s news item from the U.S. Senate Committee on Health, Education, Labor & Pensions (“Chairman Sanders, Baldwin, Luján, Markey Launch HELP Committee Investigation into Efforts by Pharmaceutical Companies to Manipulate the Price of Asthma Inhalers). In it, Senator Bernie Sanders pointed to the more than 12-fold higher cost in the United States compared with the United Kingdom for GSK’s inhaler combining fluticasone and a beta2 agonist. The Senate HELP Committee has sent letters to the CEOs of the four major inhaler manufacturers (AstraZeneca, Boehringer Ingelheim, GSK, and Teva), stating: “These prices force patients, especially the uninsured and underinsured, to ration doses or abandon their prescriptions altogether. The results are predictable and devastating.”
 

High costs of inhalers could lead to rationing

AAFA research, the AAFA press release states, confirms that when asthma medicine costs become a barrier to treatment, people with asthma ration or discontinue medication use. The release also includes Mr. Mendez’s plea for a broad national conversation. “We are hopeful the HELP Committee investigation will lead to a national conversation about asthma drug costs and produce action that breaks down barriers to affordable treatment for people with asthma. The bottom line is that cost drives access. We understand the barriers, now it is important to move toward solutions.”

AAFA’s blog advises that when an individual’s insurance plan does not cover the authorized generic and does not offer a formulary exception, other inhaler options include ArmonAir Digihaler and Arnuity Ellipta. Because these are not identical to the authorized generics, individuals should check with their doctors regarding available doses and inhaler types and, if necessary, request training on inhaler use.

“It is really important for people with asthma to continue their asthma control medicines, especially during respiratory illness season.” AAFA urges individuals with asthma who are currently Flovent users to check with their doctors or pharmacists about the best next steps for them.

A recent alert posted on the Asthma and Allergy Foundation of America (AAFA) website blog announced, “Flovent HFA and Flovent Diskus Asthma Medicine Being Discontinued.” A further heading positioned next to images of the two red inhaler devices stated: “Generic versions of the same medicines and devices are available but you need to check your insurance.” While few, it is generally thought, will have trouble finding suitable alternatives, the warning captured the reality descending upon some individual asthma sufferers whose insurance coverage may need tweaking at the very least, or at worst may be lacking.

The AAFA blog included a GSK (GlaxoSmithKline) November 2023 statement to AAFA regarding the brand name FLOVENT discontinuation. It noted the launch of an authorized Flovent HFA (fluticasone propionate inhalation aerosol) generic in May 2022 and a planned (October 2023) launch of an authorized generic for Flovent Diskus (fluticasone propionate inhalation powder) as “part of our commitment to be ambitious for patients.” The GSK statement continues: “These GSK manufactured authorized generics will provide patients in the US with potentially lower cost alternatives of these medically important products. We recognize that patients have a number of options in the therapeutic area and therefore remain committed to ensuring the affordability of our medicines.”

GSK will continue to manufacture the authorized generics, but they will be distributed by Prasco LLC.
 

Medicaid Rebate Cap Removed

As a Forbes article on January 3, 2024, by Joshua Cohen (“New Medicaid Rebate Rule Causes Problems For Asthma Patients On Flovent”) points out, the Flovent January 1, 2024, discontinuation coincided with the removal of the Medicaid rebate cap (American Rescue Plan Medicaid Drug Rebate Program) targeting manufacturers who had previously raised medication prices at rates higher than the inflation rate. The Forbes story notes GoodRx data showing a 47% increase in Flovent price since 2014. The implication is that drug manufacturers could be forced to sell such a drug to Medicaid at a loss because of the rebate cap removal. An authorized generic introduced to the market at a lower price under a private label with no price history, however, would not be subject to the higher Medicaid rebates.

Motivation considerations aside, the fallout for patients may or may not include a lower cost alternative. The authorized generic versions of Flovent HFA and Flovent Diskus are identical to the branded products with respect to the drugs and the devices. The GSK statement expressed hope that most insurance plans will replace the brand name with the authorized generic. The possibility persists, however, that there may be some that do not — resulting in a need to find the right substitute and/or higher out-of-pocket costs.

“Even though some patients may experience some disruption initially in their prescriptions,” Diego J. Maselli, MD, professor and chief, division of pulmonary diseases and critical care, UT Health at San Antonio, Texas, said in an interview, “fortunately, there are quite a few alternatives, and we don’t anticipate significant problems. It will be a wrinkle for some of the patients with regard to coverage, but there are definitely many alternatives that can provide good enough treatment for them.”
 

Similar alternative inhalers?

The alternatives have their specific properties and qualities, but the vast majority of experts, Dr. Maselli said, consider them to be very similar.

For CAREMARK CVS, a major pharmaceutical benefits manager, the preferred Flovent substitute is Pulmicort Flexhaler, a dry-powder inhaler that contains budesonide rather than fluticasone. While Flovent HF is a metered dose inhaler with a propellant, the Pulmicort device contains budesonide as a dry powder and requires activation through inhalation, which can be problematic for young children, AAFA CEO Kenneth Mendez said in an interview. To address that issue, he said, CVS Caremark is covering the authorized fluticasone metered dose inhaler generic for children under 6 years old. “Those individuals 6 years and older with severe asthma who can’t breathe deeply enough to get the medicine into their lungs will have to work with their doctors to apply for a formulary exception. And that’s a complicated process,” Mr. Mendez observed. “And it can take some time,” he added.

Another key issue highlighted here, he emphasized, is “how complicated this system is.” The U.S. drug pricing ecosystem involves multiple manufacturers, pharmacy benefit managers, insurance companies and their various plans, and federal policies potentially creating situations that may reduce access to critical medicines for patients, Mr. Mendez said. “Some people will be scurrying and scrambling to try to get coverage. The scope of the impact is actually unknown, but we’re going to find out now. As a nonprofit, we monitor social media and we’re listening closely.”

AAFA’s further concern is the rising costs of asthma medications. “It’s the number one thing we hear about as a patient organization,” Mr. Mendez said. On January 9, 2024, AAFA issued a press release praising the previous day’s news item from the U.S. Senate Committee on Health, Education, Labor & Pensions (“Chairman Sanders, Baldwin, Luján, Markey Launch HELP Committee Investigation into Efforts by Pharmaceutical Companies to Manipulate the Price of Asthma Inhalers). In it, Senator Bernie Sanders pointed to the more than 12-fold higher cost in the United States compared with the United Kingdom for GSK’s inhaler combining fluticasone and a beta2 agonist. The Senate HELP Committee has sent letters to the CEOs of the four major inhaler manufacturers (AstraZeneca, Boehringer Ingelheim, GSK, and Teva), stating: “These prices force patients, especially the uninsured and underinsured, to ration doses or abandon their prescriptions altogether. The results are predictable and devastating.”
 

High costs of inhalers could lead to rationing

AAFA research, the AAFA press release states, confirms that when asthma medicine costs become a barrier to treatment, people with asthma ration or discontinue medication use. The release also includes Mr. Mendez’s plea for a broad national conversation. “We are hopeful the HELP Committee investigation will lead to a national conversation about asthma drug costs and produce action that breaks down barriers to affordable treatment for people with asthma. The bottom line is that cost drives access. We understand the barriers, now it is important to move toward solutions.”

AAFA’s blog advises that when an individual’s insurance plan does not cover the authorized generic and does not offer a formulary exception, other inhaler options include ArmonAir Digihaler and Arnuity Ellipta. Because these are not identical to the authorized generics, individuals should check with their doctors regarding available doses and inhaler types and, if necessary, request training on inhaler use.

“It is really important for people with asthma to continue their asthma control medicines, especially during respiratory illness season.” AAFA urges individuals with asthma who are currently Flovent users to check with their doctors or pharmacists about the best next steps for them.

The impact of maternal factors on allergy and asthma is the subject of new research in the wake of a grant from the National Institute of Allergy and Infectious Diseases to a team at Indiana University School of Medicine, according to a university press release.

Researchers led by Joan Cook-Mills, PhD, will examine the mechanisms behind the development of asthma, food allergies, and allergic diseases in children whose mothers had allergies.

“Research from the Cook-Mills lab revealed mothers with allergies have elevated levels of a specific lipid within the eicosanoid class of lipids, suggesting this lipid may have a potential influence on their offspring also developing allergies,” according to the press release.

A 5-year grant for $3.9 million was awarded to extend work by the Cook-Mills lab, and the research will focus on four areas, according to the university:

The potential impact of higher levels of lipid from mothers’ lungs may affect infants’ risk for allergy and whether this lipid is transmitted to infants during pregnancy or breastfeeding.

The potential impact of elevated levels of a specific eicosanoid in mothers with allergies promotes the creation of more dendritic cells by fetal bone marrow and how this might affect allergy risk for infants.

The potential impact of elevated eicosanoids in allergic mothers can affect the lung microbiome in mothers and their offspring, potentially leading to altered lung bacteria, which can affect immune cell responses to allergies and asthma.

The potential impact of elevated eicosanoids on whether the altered lung microbiome “actively changes the production of this eicosanoid in the lungs of allergic mothers,” according to the press release.

“Allergies and asthma cause a significant burden of disease in our pediatric population, which is further complicated by limited therapies and interventions to combat these diseases, let alone prevent their development,” Anne C. Coates, MD, a pediatric pulmonologist at Maine Medical Center, Portland, said in an interview.

“The work by Cook-Mills and her colleagues will expand our understanding of the role maternal health may have on allergies and asthma and opportunities to mitigate it,” she said. The key implications of the research are the potential to facilitate the development of future clinical studies and trials that could yield novel targeted treatments for significant allergies, Dr. Coates told this news organization.

The research by Cook-Mills and her team had “the potential for the development of transformative approaches to allergy prevention and management, which could improve the health and quality of life for scores of individuals worldwide,” she said.

Dr. Coates had no financial conflicts to disclose but served on the Editorial Advisory Board of Chest Physician.

A version of this article appeared on Medscape.com.

The impact of maternal factors on allergy and asthma is the subject of new research in the wake of a grant from the National Institute of Allergy and Infectious Diseases to a team at Indiana University School of Medicine, according to a university press release.

Researchers led by Joan Cook-Mills, PhD, will examine the mechanisms behind the development of asthma, food allergies, and allergic diseases in children whose mothers had allergies.

“Research from the Cook-Mills lab revealed mothers with allergies have elevated levels of a specific lipid within the eicosanoid class of lipids, suggesting this lipid may have a potential influence on their offspring also developing allergies,” according to the press release.

A 5-year grant for $3.9 million was awarded to extend work by the Cook-Mills lab, and the research will focus on four areas, according to the university:

The potential impact of higher levels of lipid from mothers’ lungs may affect infants’ risk for allergy and whether this lipid is transmitted to infants during pregnancy or breastfeeding.

The potential impact of elevated levels of a specific eicosanoid in mothers with allergies promotes the creation of more dendritic cells by fetal bone marrow and how this might affect allergy risk for infants.

The potential impact of elevated eicosanoids in allergic mothers can affect the lung microbiome in mothers and their offspring, potentially leading to altered lung bacteria, which can affect immune cell responses to allergies and asthma.

The potential impact of elevated eicosanoids on whether the altered lung microbiome “actively changes the production of this eicosanoid in the lungs of allergic mothers,” according to the press release.

“Allergies and asthma cause a significant burden of disease in our pediatric population, which is further complicated by limited therapies and interventions to combat these diseases, let alone prevent their development,” Anne C. Coates, MD, a pediatric pulmonologist at Maine Medical Center, Portland, said in an interview.

“The work by Cook-Mills and her colleagues will expand our understanding of the role maternal health may have on allergies and asthma and opportunities to mitigate it,” she said. The key implications of the research are the potential to facilitate the development of future clinical studies and trials that could yield novel targeted treatments for significant allergies, Dr. Coates told this news organization.

The research by Cook-Mills and her team had “the potential for the development of transformative approaches to allergy prevention and management, which could improve the health and quality of life for scores of individuals worldwide,” she said.

Dr. Coates had no financial conflicts to disclose but served on the Editorial Advisory Board of Chest Physician.

A version of this article appeared on Medscape.com.

The impact of maternal factors on allergy and asthma is the subject of new research in the wake of a grant from the National Institute of Allergy and Infectious Diseases to a team at Indiana University School of Medicine, according to a university press release.

Researchers led by Joan Cook-Mills, PhD, will examine the mechanisms behind the development of asthma, food allergies, and allergic diseases in children whose mothers had allergies.

“Research from the Cook-Mills lab revealed mothers with allergies have elevated levels of a specific lipid within the eicosanoid class of lipids, suggesting this lipid may have a potential influence on their offspring also developing allergies,” according to the press release.

A 5-year grant for $3.9 million was awarded to extend work by the Cook-Mills lab, and the research will focus on four areas, according to the university:

The potential impact of higher levels of lipid from mothers’ lungs may affect infants’ risk for allergy and whether this lipid is transmitted to infants during pregnancy or breastfeeding.

The potential impact of elevated levels of a specific eicosanoid in mothers with allergies promotes the creation of more dendritic cells by fetal bone marrow and how this might affect allergy risk for infants.

The potential impact of elevated eicosanoids in allergic mothers can affect the lung microbiome in mothers and their offspring, potentially leading to altered lung bacteria, which can affect immune cell responses to allergies and asthma.

The potential impact of elevated eicosanoids on whether the altered lung microbiome “actively changes the production of this eicosanoid in the lungs of allergic mothers,” according to the press release.

“Allergies and asthma cause a significant burden of disease in our pediatric population, which is further complicated by limited therapies and interventions to combat these diseases, let alone prevent their development,” Anne C. Coates, MD, a pediatric pulmonologist at Maine Medical Center, Portland, said in an interview.

“The work by Cook-Mills and her colleagues will expand our understanding of the role maternal health may have on allergies and asthma and opportunities to mitigate it,” she said. The key implications of the research are the potential to facilitate the development of future clinical studies and trials that could yield novel targeted treatments for significant allergies, Dr. Coates told this news organization.

The research by Cook-Mills and her team had “the potential for the development of transformative approaches to allergy prevention and management, which could improve the health and quality of life for scores of individuals worldwide,” she said.

Dr. Coates had no financial conflicts to disclose but served on the Editorial Advisory Board of Chest Physician.

A version of this article appeared on Medscape.com.

Can asthma symptoms be monitored reliably at home? Until now, the answer would have been yes, but not in preschool-age patients. Recent findings in Annals of Family Medicine suggest that this limitation can be overcome with the assistance of artificial intelligence (AI). The use of an AI-assisted stethoscope can generate reliable data, even in young children, thus providing caregivers with information about asthma exacerbations.

Objectivity Challenge

A timely diagnosis of asthma exacerbations, which is crucial for proper disease management, requires effective home monitoring. While some lung function parameters, like peak expiratory flow (PEF), can be measured by patients at home, tools for this purpose are not designed for very young children.

“To achieve effective asthma management, patients should be given the necessary tools to allow them to recognize and respond to worsening asthma,” wrote the study authors. Despite the Global Initiative for Asthma identifying respiratory sounds as a fundamental parameter for exacerbation recognition, these are almost exclusively evaluated during doctor visits. Recognizing respiratory sounds and judging whether there has been a change can be challenging for those outside the medical profession.

To enhance home monitoring, researchers from the Department of Pediatric Pneumology and Rheumatology at the University of Lublin, Poland, experimented with the StethoMe stethoscope, which enables the recognition of pathologic signs, including continuous and transient noises. This AI-assisted stethoscope, trained on over 10,000 respiratory sound recordings, is certified as a Class IIa medical device in Europe.
 

The ‘Smart’ Stethoscope

The 6-month study enlisted 149 patients with asthma (90 children and 59 adults). Participants self-monitored (but parents or caregivers managed for children) once daily in the first 2 weeks and at least once weekly thereafter using three tools. The first was the StethoMe stethoscope, which was used for detecting respiratory sounds, respiratory rate (RR), heart rate (HR), and inspiration/expiration ratio (I/E). Patients were provided a “map” of chest points at which to position the stethoscope. The second was a pulse oximeter, which was used to measure oxygen saturation. The third was a peak flow meter for quantifying PEF. Simultaneously, a health questionnaire was completed.

Data from 6029 completed self-monitoring sessions were used to determine the most effective parameter for exacerbation recognition, quantified by the area under the receiver operating characteristic curve (AUC). The researchers concluded that the parameter with the best performance was wheeze intensity in young children (AUC 84%, 95% CI, 82%-85%), wheeze intensity in older children (AUC, 81%; 95% CI, 79%-84%), and questionnaire response for adults (AUC, 92%; 95% CI, 89%-95%). Combining multiple parameters increased effectiveness.

“The present results clearly show that a set of parameters (wheezes, rhonchi, coarse and fine crackles, HR, RR, and I/E) measured by a device such as an AI-aided home stethoscope allows for the detection of exacerbations without the need for performing PEF measurements, which can be equivocal,” the study authors concluded. “In addition, in the case of younger children (age, < 5 years), when introduced on a large scale, the analyzed home stethoscope appears to be a promising tool that might make asthma diagnosis more straightforward and substantially facilitate asthma monitoring.”

A version of this article first appeared on Medscape.com. This article was translated from Univadis Italy, which is part of the Medscape professional network.

Can asthma symptoms be monitored reliably at home? Until now, the answer would have been yes, but not in preschool-age patients. Recent findings in Annals of Family Medicine suggest that this limitation can be overcome with the assistance of artificial intelligence (AI). The use of an AI-assisted stethoscope can generate reliable data, even in young children, thus providing caregivers with information about asthma exacerbations.

Objectivity Challenge

A timely diagnosis of asthma exacerbations, which is crucial for proper disease management, requires effective home monitoring. While some lung function parameters, like peak expiratory flow (PEF), can be measured by patients at home, tools for this purpose are not designed for very young children.

“To achieve effective asthma management, patients should be given the necessary tools to allow them to recognize and respond to worsening asthma,” wrote the study authors. Despite the Global Initiative for Asthma identifying respiratory sounds as a fundamental parameter for exacerbation recognition, these are almost exclusively evaluated during doctor visits. Recognizing respiratory sounds and judging whether there has been a change can be challenging for those outside the medical profession.

To enhance home monitoring, researchers from the Department of Pediatric Pneumology and Rheumatology at the University of Lublin, Poland, experimented with the StethoMe stethoscope, which enables the recognition of pathologic signs, including continuous and transient noises. This AI-assisted stethoscope, trained on over 10,000 respiratory sound recordings, is certified as a Class IIa medical device in Europe.
 

The ‘Smart’ Stethoscope

The 6-month study enlisted 149 patients with asthma (90 children and 59 adults). Participants self-monitored (but parents or caregivers managed for children) once daily in the first 2 weeks and at least once weekly thereafter using three tools. The first was the StethoMe stethoscope, which was used for detecting respiratory sounds, respiratory rate (RR), heart rate (HR), and inspiration/expiration ratio (I/E). Patients were provided a “map” of chest points at which to position the stethoscope. The second was a pulse oximeter, which was used to measure oxygen saturation. The third was a peak flow meter for quantifying PEF. Simultaneously, a health questionnaire was completed.

Data from 6029 completed self-monitoring sessions were used to determine the most effective parameter for exacerbation recognition, quantified by the area under the receiver operating characteristic curve (AUC). The researchers concluded that the parameter with the best performance was wheeze intensity in young children (AUC 84%, 95% CI, 82%-85%), wheeze intensity in older children (AUC, 81%; 95% CI, 79%-84%), and questionnaire response for adults (AUC, 92%; 95% CI, 89%-95%). Combining multiple parameters increased effectiveness.

“The present results clearly show that a set of parameters (wheezes, rhonchi, coarse and fine crackles, HR, RR, and I/E) measured by a device such as an AI-aided home stethoscope allows for the detection of exacerbations without the need for performing PEF measurements, which can be equivocal,” the study authors concluded. “In addition, in the case of younger children (age, < 5 years), when introduced on a large scale, the analyzed home stethoscope appears to be a promising tool that might make asthma diagnosis more straightforward and substantially facilitate asthma monitoring.”

A version of this article first appeared on Medscape.com. This article was translated from Univadis Italy, which is part of the Medscape professional network.

Can asthma symptoms be monitored reliably at home? Until now, the answer would have been yes, but not in preschool-age patients. Recent findings in Annals of Family Medicine suggest that this limitation can be overcome with the assistance of artificial intelligence (AI). The use of an AI-assisted stethoscope can generate reliable data, even in young children, thus providing caregivers with information about asthma exacerbations.

Objectivity Challenge

A timely diagnosis of asthma exacerbations, which is crucial for proper disease management, requires effective home monitoring. While some lung function parameters, like peak expiratory flow (PEF), can be measured by patients at home, tools for this purpose are not designed for very young children.

“To achieve effective asthma management, patients should be given the necessary tools to allow them to recognize and respond to worsening asthma,” wrote the study authors. Despite the Global Initiative for Asthma identifying respiratory sounds as a fundamental parameter for exacerbation recognition, these are almost exclusively evaluated during doctor visits. Recognizing respiratory sounds and judging whether there has been a change can be challenging for those outside the medical profession.

To enhance home monitoring, researchers from the Department of Pediatric Pneumology and Rheumatology at the University of Lublin, Poland, experimented with the StethoMe stethoscope, which enables the recognition of pathologic signs, including continuous and transient noises. This AI-assisted stethoscope, trained on over 10,000 respiratory sound recordings, is certified as a Class IIa medical device in Europe.
 

The ‘Smart’ Stethoscope

The 6-month study enlisted 149 patients with asthma (90 children and 59 adults). Participants self-monitored (but parents or caregivers managed for children) once daily in the first 2 weeks and at least once weekly thereafter using three tools. The first was the StethoMe stethoscope, which was used for detecting respiratory sounds, respiratory rate (RR), heart rate (HR), and inspiration/expiration ratio (I/E). Patients were provided a “map” of chest points at which to position the stethoscope. The second was a pulse oximeter, which was used to measure oxygen saturation. The third was a peak flow meter for quantifying PEF. Simultaneously, a health questionnaire was completed.

Data from 6029 completed self-monitoring sessions were used to determine the most effective parameter for exacerbation recognition, quantified by the area under the receiver operating characteristic curve (AUC). The researchers concluded that the parameter with the best performance was wheeze intensity in young children (AUC 84%, 95% CI, 82%-85%), wheeze intensity in older children (AUC, 81%; 95% CI, 79%-84%), and questionnaire response for adults (AUC, 92%; 95% CI, 89%-95%). Combining multiple parameters increased effectiveness.

“The present results clearly show that a set of parameters (wheezes, rhonchi, coarse and fine crackles, HR, RR, and I/E) measured by a device such as an AI-aided home stethoscope allows for the detection of exacerbations without the need for performing PEF measurements, which can be equivocal,” the study authors concluded. “In addition, in the case of younger children (age, < 5 years), when introduced on a large scale, the analyzed home stethoscope appears to be a promising tool that might make asthma diagnosis more straightforward and substantially facilitate asthma monitoring.”

A version of this article first appeared on Medscape.com. This article was translated from Univadis Italy, which is part of the Medscape professional network.

Sabine Roman, MD, PhD, associate professor of gastroenterology and physiology at Lyon University Hospital in France, took the floor at the United European Gastroenterology Week to discuss the link between a chronic cough and gastroesophageal reflux disease (GERD). During a session on extraesophageal symptoms, Dr. Roman relayed two key messages: In patients with a chronic cough, reflux absolutely must be documented, and proton pump inhibitors (PPIs) must only be prescribed when a diagnosis of GERD has been made.
 

Overestimated Cause

Chronic cough is a widespread problem with a prevalence of between 9% and 33%, according to clinical studies. The root causes of this cough are varied; they’re mainly related to the respiratory system (eg, asthma, chronic obstructive pulmonary disease, respiratory infections, or smoking) and the ear, nose, and throat field (eg, postnasal drip). What’s more, taking certain medicines, notably angiotensin-converting enzyme inhibitors, can also be at the root of this condition.

GERD is also a possible cause of a chronic cough but one that is likely overestimated. A 2023 Spanish study provides evidence of this; GERD was suspected to be linked to cough in 46% of patients (compared with 32% for asthma and 15% for postnasal drip).

The treatments most commonly prescribed include PPIs (79.6%) and respiratory medicines (87.8%). Note that antibiotics are administered empirically to 28.6% of patients. For Roman, “the blame for a chronic cough is too often assigned to GERD, especially considering that in this study, only 43% of patients had seen a gastroenterologist, 27% had an endoscopy, and 24% had undergone esophageal pH monitoring.”

Added to this observation is the difficulty of establishing a causal link between a cough and GERD when the latter is present, even when the patient has had a diagnosis of GERD. Of course, a link between the two does not necessarily imply a cause–effect relationship, especially given that studies have shown that a cough itself can induce GERD. Studies using automatic cough detection to count cough events have shown that GERD certainly preceded a cough in 48% of patients, but in 56% of cases, it was the cough that came before the GERD. What’s more, both mechanisms were present in one third of patients.
 

Prescribing PPIs Effectively

PPIs are commonly prescribed as a test treatment. However, their efficacy is in no way proof of the existence of underlying GERD. In reality, all placebo-controlled studies have shown that in cases where no prior diagnosis of GERD has been made, PPIs have no superior efficacy.

If reflux has been proven, then the improvement provided by PPIs, compared with placebo, is between 12% and 35%. Therefore, it is essential that the presence of GERD be demonstrated, particularly if the patient has no characteristic symptoms of GERD, such as heartburn and acid reflux.

Response factors to PPIs were evaluated in 178 Italian patients with a chronic cough who presented with suspected GERD. Of those, 45% responded to treatment. It has been shown that typical symptoms, severe esophagitis (grade C/D), abnormal acid exposure, and low levels of nocturnal baseline impedance were independent factors of response to treatment.

In conclusion, patients with a chronic cough must be comprehensively tested for GERD before a long-term prescription of PPIs can be considered.
 

Cough Reflex Threshold

Various studies have also revealed that patients with GERD and presenting with a chronic cough have an increased sensitivity to the cough reflex. This hypersensitivity to the cough reflex has inspired several trials involving gabapentin and baclofen. A randomized controlled trial found the two treatments to be equally effective, achieving improvement of around 50%.

Lesogaberan, a new GABA(B) receptor agonist acting on the peripheral nervous system which is better tolerated than baclofen, a drug belonging to the same therapeutic class, showed a 26% benefit over placebo, but it was not statistically significant; lesogaberan has not been developed further.

Anti-reflux surgery is an option. A 2021 meta-analysis revealed that 84% of patients enrolled in these studies saw an improvement in their symptoms. However, these results must be regarded with caution because none of these studies were controlled, most of them were retrospective with very heterogeneous patient populations, and the data obtained on postoperative reflux control were often found to be lacking.

A retrospective study showed that among the factors for nonresponse or recurrence of symptoms after anti-reflux surgery, lack of response to medical treatment and extraesophageal symptoms such as a cough were significant factors. Consequently, potential candidates for surgery must be rigorously screened before being considered for such a procedure.

The recent recommendations for good practice published by the American Gastroenterological Association also insist that lack of response to medical treatment is a major factor for failure of surgical treatment.

In sum, patients with a chronic cough can be prescribed PPIs as first-line treatment if they have typical symptoms of GERD. In the event of treatment failure or isolated cough without typical symptoms, tests to confirm or rule out GERD are essential (such as endoscopy, esophageal pH monitoring, or impedance-pH monitoring).
 

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

Sabine Roman, MD, PhD, associate professor of gastroenterology and physiology at Lyon University Hospital in France, took the floor at the United European Gastroenterology Week to discuss the link between a chronic cough and gastroesophageal reflux disease (GERD). During a session on extraesophageal symptoms, Dr. Roman relayed two key messages: In patients with a chronic cough, reflux absolutely must be documented, and proton pump inhibitors (PPIs) must only be prescribed when a diagnosis of GERD has been made.
 

Overestimated Cause

Chronic cough is a widespread problem with a prevalence of between 9% and 33%, according to clinical studies. The root causes of this cough are varied; they’re mainly related to the respiratory system (eg, asthma, chronic obstructive pulmonary disease, respiratory infections, or smoking) and the ear, nose, and throat field (eg, postnasal drip). What’s more, taking certain medicines, notably angiotensin-converting enzyme inhibitors, can also be at the root of this condition.

GERD is also a possible cause of a chronic cough but one that is likely overestimated. A 2023 Spanish study provides evidence of this; GERD was suspected to be linked to cough in 46% of patients (compared with 32% for asthma and 15% for postnasal drip).

The treatments most commonly prescribed include PPIs (79.6%) and respiratory medicines (87.8%). Note that antibiotics are administered empirically to 28.6% of patients. For Roman, “the blame for a chronic cough is too often assigned to GERD, especially considering that in this study, only 43% of patients had seen a gastroenterologist, 27% had an endoscopy, and 24% had undergone esophageal pH monitoring.”

Added to this observation is the difficulty of establishing a causal link between a cough and GERD when the latter is present, even when the patient has had a diagnosis of GERD. Of course, a link between the two does not necessarily imply a cause–effect relationship, especially given that studies have shown that a cough itself can induce GERD. Studies using automatic cough detection to count cough events have shown that GERD certainly preceded a cough in 48% of patients, but in 56% of cases, it was the cough that came before the GERD. What’s more, both mechanisms were present in one third of patients.
 

Prescribing PPIs Effectively

PPIs are commonly prescribed as a test treatment. However, their efficacy is in no way proof of the existence of underlying GERD. In reality, all placebo-controlled studies have shown that in cases where no prior diagnosis of GERD has been made, PPIs have no superior efficacy.

If reflux has been proven, then the improvement provided by PPIs, compared with placebo, is between 12% and 35%. Therefore, it is essential that the presence of GERD be demonstrated, particularly if the patient has no characteristic symptoms of GERD, such as heartburn and acid reflux.

Response factors to PPIs were evaluated in 178 Italian patients with a chronic cough who presented with suspected GERD. Of those, 45% responded to treatment. It has been shown that typical symptoms, severe esophagitis (grade C/D), abnormal acid exposure, and low levels of nocturnal baseline impedance were independent factors of response to treatment.

In conclusion, patients with a chronic cough must be comprehensively tested for GERD before a long-term prescription of PPIs can be considered.
 

Cough Reflex Threshold

Various studies have also revealed that patients with GERD and presenting with a chronic cough have an increased sensitivity to the cough reflex. This hypersensitivity to the cough reflex has inspired several trials involving gabapentin and baclofen. A randomized controlled trial found the two treatments to be equally effective, achieving improvement of around 50%.

Lesogaberan, a new GABA(B) receptor agonist acting on the peripheral nervous system which is better tolerated than baclofen, a drug belonging to the same therapeutic class, showed a 26% benefit over placebo, but it was not statistically significant; lesogaberan has not been developed further.

Anti-reflux surgery is an option. A 2021 meta-analysis revealed that 84% of patients enrolled in these studies saw an improvement in their symptoms. However, these results must be regarded with caution because none of these studies were controlled, most of them were retrospective with very heterogeneous patient populations, and the data obtained on postoperative reflux control were often found to be lacking.

A retrospective study showed that among the factors for nonresponse or recurrence of symptoms after anti-reflux surgery, lack of response to medical treatment and extraesophageal symptoms such as a cough were significant factors. Consequently, potential candidates for surgery must be rigorously screened before being considered for such a procedure.

The recent recommendations for good practice published by the American Gastroenterological Association also insist that lack of response to medical treatment is a major factor for failure of surgical treatment.

In sum, patients with a chronic cough can be prescribed PPIs as first-line treatment if they have typical symptoms of GERD. In the event of treatment failure or isolated cough without typical symptoms, tests to confirm or rule out GERD are essential (such as endoscopy, esophageal pH monitoring, or impedance-pH monitoring).
 

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

Sabine Roman, MD, PhD, associate professor of gastroenterology and physiology at Lyon University Hospital in France, took the floor at the United European Gastroenterology Week to discuss the link between a chronic cough and gastroesophageal reflux disease (GERD). During a session on extraesophageal symptoms, Dr. Roman relayed two key messages: In patients with a chronic cough, reflux absolutely must be documented, and proton pump inhibitors (PPIs) must only be prescribed when a diagnosis of GERD has been made.
 

Overestimated Cause

Chronic cough is a widespread problem with a prevalence of between 9% and 33%, according to clinical studies. The root causes of this cough are varied; they’re mainly related to the respiratory system (eg, asthma, chronic obstructive pulmonary disease, respiratory infections, or smoking) and the ear, nose, and throat field (eg, postnasal drip). What’s more, taking certain medicines, notably angiotensin-converting enzyme inhibitors, can also be at the root of this condition.

GERD is also a possible cause of a chronic cough but one that is likely overestimated. A 2023 Spanish study provides evidence of this; GERD was suspected to be linked to cough in 46% of patients (compared with 32% for asthma and 15% for postnasal drip).

The treatments most commonly prescribed include PPIs (79.6%) and respiratory medicines (87.8%). Note that antibiotics are administered empirically to 28.6% of patients. For Roman, “the blame for a chronic cough is too often assigned to GERD, especially considering that in this study, only 43% of patients had seen a gastroenterologist, 27% had an endoscopy, and 24% had undergone esophageal pH monitoring.”

Added to this observation is the difficulty of establishing a causal link between a cough and GERD when the latter is present, even when the patient has had a diagnosis of GERD. Of course, a link between the two does not necessarily imply a cause–effect relationship, especially given that studies have shown that a cough itself can induce GERD. Studies using automatic cough detection to count cough events have shown that GERD certainly preceded a cough in 48% of patients, but in 56% of cases, it was the cough that came before the GERD. What’s more, both mechanisms were present in one third of patients.
 

Prescribing PPIs Effectively

PPIs are commonly prescribed as a test treatment. However, their efficacy is in no way proof of the existence of underlying GERD. In reality, all placebo-controlled studies have shown that in cases where no prior diagnosis of GERD has been made, PPIs have no superior efficacy.

If reflux has been proven, then the improvement provided by PPIs, compared with placebo, is between 12% and 35%. Therefore, it is essential that the presence of GERD be demonstrated, particularly if the patient has no characteristic symptoms of GERD, such as heartburn and acid reflux.

Response factors to PPIs were evaluated in 178 Italian patients with a chronic cough who presented with suspected GERD. Of those, 45% responded to treatment. It has been shown that typical symptoms, severe esophagitis (grade C/D), abnormal acid exposure, and low levels of nocturnal baseline impedance were independent factors of response to treatment.

In conclusion, patients with a chronic cough must be comprehensively tested for GERD before a long-term prescription of PPIs can be considered.
 

Cough Reflex Threshold

Various studies have also revealed that patients with GERD and presenting with a chronic cough have an increased sensitivity to the cough reflex. This hypersensitivity to the cough reflex has inspired several trials involving gabapentin and baclofen. A randomized controlled trial found the two treatments to be equally effective, achieving improvement of around 50%.

Lesogaberan, a new GABA(B) receptor agonist acting on the peripheral nervous system which is better tolerated than baclofen, a drug belonging to the same therapeutic class, showed a 26% benefit over placebo, but it was not statistically significant; lesogaberan has not been developed further.

Anti-reflux surgery is an option. A 2021 meta-analysis revealed that 84% of patients enrolled in these studies saw an improvement in their symptoms. However, these results must be regarded with caution because none of these studies were controlled, most of them were retrospective with very heterogeneous patient populations, and the data obtained on postoperative reflux control were often found to be lacking.

A retrospective study showed that among the factors for nonresponse or recurrence of symptoms after anti-reflux surgery, lack of response to medical treatment and extraesophageal symptoms such as a cough were significant factors. Consequently, potential candidates for surgery must be rigorously screened before being considered for such a procedure.

The recent recommendations for good practice published by the American Gastroenterological Association also insist that lack of response to medical treatment is a major factor for failure of surgical treatment.

In sum, patients with a chronic cough can be prescribed PPIs as first-line treatment if they have typical symptoms of GERD. In the event of treatment failure or isolated cough without typical symptoms, tests to confirm or rule out GERD are essential (such as endoscopy, esophageal pH monitoring, or impedance-pH monitoring).
 

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.