Abstract
Background
Chronic 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).
Method
These 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.
Results
The 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).
Conclusions
Aclidinium 400 µg BID may provide improvements in cough and sputum expectoration.
- © 2014 ERS
