RT Journal Article
SR Electronic
T1 The effect of twice-daily aclidinium bromide on cough and sputum in patients with COPD: Results from phase III studies
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P920
VO 44
IS Suppl 58
A1 McGarvey, Lorcan
A1 Morice, Alyn
A1 Smith, Jacky
A1 Birring, Surinder
A1 Chuecos, Ferran
A1 Seoane, Beatriz
A1 Jarreta, Diana
YR 2014
UL http://erj.ersjournals.com/content/44/Suppl_58/P920.abstract
AB BackgroundChronic cough and sputum production are troublesome symptoms in COPD. Three Phase III studies assessed the effect of aclidinium 400 µg twice-daily (BID) on cough and sputum severity in patients with moderate-to-severe COPD (not selected for these symptoms).MethodThese were randomized, double-blind, placebo-controlled studies. Patients were randomized to BID placebo, aclidinium 200 µg or aclidinium 400 µg (ACCORD COPD I [12 weeks] and ATTAIN [24 weeks]) and placebo, aclidinium 400 µg or tiotropium 18 µg once-daily (LAS39; 6 weeks). Changes from baseline in EXAcerbations of Chronic pulmonary disease Tool-Respiratory Symptoms (E-RS) total and cough/sputum domain scores and morning/night-time cough and phlegm symptoms (symptom questionnaires) were assessed.ResultsThe ITT population included 559 (mean age 64 years; 53% male; mean post-bronchodilator FEV1 54% predicted), 819 (62 years; 67% male; FEV1 57% predicted) and 414 (62 years; 67% male; FEV1 56% predicted) patients in ACCORD, ATTAIN, and LAS39, respectively.E-RS cough/sputum domain scores were lower with aclidinium 400 µg than placebo (both p<0.01; Table). Morning and night-time cough severity, morning difficulty bringing up phlegm and night-time sputum production were also reduced with aclidinium 400 µg (all p<0.05 vs placebo; Table).ConclusionsAclidinium 400 µg BID may provide improvements in cough and sputum expectoration.