DENVER – In a year-long multicenter trial, improvements in respiratory health status were more likely to be reported by COPD patients who received nebulized arformoterol tartrate, compared with those who received placebo as part of their treatment regimen.
“We can’t say it’s a blockbuster improvement in quality of life, but it’s still good,” lead study author Dr. James F. Donohue said in an interview at an international conference of the American Thoracic Society.
Doug Brunk/Frontline Medical News
Dr. James F. Donohue
In a secondary analysis of data from a published clinical trial (Chest 2014;146:1531-42), Dr. Donohue and his associates evaluated 420 patients with moderate to severe COPD who received nebulized arformoterol 15 mcg b.i.d. and 421 who received matched placebo for 52 weeks. Eligibility criteria included being at least 40 years of age and having a documented primary diagnosis of nonasthmatic COPD. With the exception of other long-acting beta-2 agonists, treatment with other COPD medications was permitted.
At months 3, 6, and 12, patients completed the 10-item Clinical COPD Questionnaire(CCQ), a validated, self-administered instrument. Improvement of 0.4 points or more in the CCQ total score is considered clinically significant.
At baseline, the mean age of the study participants was 63 years, 43% were female, and 51% were current smokers. A total of 466 participants completed the 12-month trial, including 255 in the arformoterol group (61%) and 211 in the placebo group (51%). Compared with patients in the placebo group, those in the arformoterol group had greater improvements on CCQ total score (–0.18 vs. 0.02, respectively; P = 0.001), symptoms (–0.21 vs. 0.01; P = 0.002), functional state (–0.17 vs. 0.02; P = 0.018), and mental state (–0.20 vs. 0.02; P = 0.023) across the postbaseline visits. At the study endpoint, 38% of patients in the arformoterol group and 31% of patients in the placebo group had clinically significant improvements on the CCQ total score.
“These are good results in a 52-week study,” said Dr. Donohue, professor of pulmonary and critical care medicine at the University of North Carolina, Chapel Hill. “What we really want is to help the patient feel better, be more mentally alert, more functional, and have less symptoms.”
The study was funded by Sunovion Pharmaceuticals, the manufacturer of arformoterol. Dr. Donohue disclosed that he is a consultant for the company.
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