On Sunday morning at the American Thoracic Society 2014 International Conference in San Diego, the focus will be on late-breaking clinical trials with presentations of the latest research from basic studies to the best contemporary patient care in disciplines ranging from pulmonary to critical care to sleep medicine and beyond. This emphasis on basic, translational, and clinical science distinguishes the ATS International Conference from other meetings.
The complete listing of this year’s presentations and their abstracts is available online. Here are highlights of five of the exceptional presentations scheduled for Sunday morning’s Late Breaking Abstracts in Clinical Trials, which will be moderated by Dr. R. Graham Barr of Columbia University, New York; Dr. Klaus F. Rabe of the University of Kiel and Clinic Grosshansdorf, Germany; and Dr. Y. Michael Shim of the University of Virginia, Charlottesville.
ASPIRE trial results
Dr. George R. Washko Jr. of Brigham and Women’s Hospital, Boston, will discuss the results of the ASPIRE trial, a multicenter, randomized, controlled study evaluating AeriSeal System endoscopic lung volume reduction therapy for chronic obstructive pulmonary disease (COPD) with advanced emphysema. The study was initiated in September 2012, and was terminated prematurely on Nov. 13, 2013, after enrollment and randomization of less than one-third of the planned patients, for nonmedical and nonregulatory reasons. Although interim results from ASPIRE confirm prior findings that hydrogel-based lung volume reduction therapy can produce improvements in advanced emphysema patient outcomes, compared with optimized medical treatment, the treatment is associated with an increased risk of adverse events requiring hospitalization, according to the researchers.
The study compared AeriSeal Lung Sealant therapy plus medical treatment to medical treatment alone. At 90-day follow-up for available patients, there was a significant improvement in forced expiratory volume in 1 second (FEV1) in the treatment group vs. the control group.
Dr. Washko will discuss how, at the time of study termination, significantly more adverse events requiring hospitalizations occurred in patients in the treatment group (43%), as compared with the control patients (15%). The majority of these events were respiratory (39% treatment vs. 15% control). There were two deaths in the treatment group (one treatment-related) and none in the control group, according to Dr. Washko and his colleagues.
RODEO trial findings
Short-term treatment with rosuvastatin in stable COPD patients without known cardiovascular disease was associated with reduced systemic inflammation, but did not improve endothelial or pulmonary function, according to the results of the RODEO (Effect of Rosuvastatin Treatment in Stable COPD) trial, which will be presented by Dr. Anke Neukamm of Akershus University Hospital, Lørenskog, Norway.
Dr. Neukamm and her colleagues tested the hypotheses that statin therapy is associated with improved endothelial and pulmonary function and reduced systemic inflammation in patients with stable COPD. In their randomized, placebo-controlled, double-blind, parallel trial, stable COPD patients (n = 99) from two hospital outpatient clinics were assigned to receive rosuvastatin 10 mg or matching placebo once daily for 12 weeks.
She will present their data showing that rosuvastatin therapy was associated with a highly significant decrease in serum LDL cholesterol, but that in the intention-to-treat analysis, no significant between-group difference in change in endothelial or pulmonary function was observed.
ACROSS trial results
In adults with severe sepsis and detectable levels of plasma cell–free hemoglobin, treatment with acetaminophen reduced oxidative injury and improved renal function, according to the results of the randomized ACROSS (Acetaminophen for the Reduction of Oxidative Injury in Patients with Severe Sepsis) trial, which will be presented by Dr. David R. Janz, a clinical fellow at Vanderbilt University, Nashville, Tenn.
Dr. Janz will report on the phase II, randomized, double-blind, placebo-controlled trial that he and his colleagues performed, comparing acetaminophen 1 g by mouth every 6 hours for 3 days versus placebo in adults with severe sepsis admitted to the intensive care unit for less than 24 hours and who had detectable plasma cell–free hemoglobin, a potent oxidant.
They found that the acetaminophen group had significantly lower levels of plasma F2-isoprostanes on study day 2 and significantly lower levels of creatinine on study day 3, although there was no statistically significant difference in hospital mortality or adverse events between the acetaminophen and placebo groups.
Beta-blocker therapy in patients with i-PAH
Dr. J.S.J.A. Van Campen, of the Institute for Cardiovascular Research, VU Medical Center, Amsterdam, and colleagues performed a randomized, controlled clinical trial of beta-blocker therapy in patients with idiopathic pulmonary arterial hypertension (i-PAH) to specifically assess the clinical effectiveness of bisoprolol.
Dr. Van Campen will present their results showing that in patients with i-PAH, beta-blocker therapy is safe and is tolerated equally as in patients with left heart failure. A significant reduction of heart rate was achieved with the tolerated dose, and right ventricular ejection fraction and quality of life improved without a significant drop in exercise capacity