The effect of aclidinium bromide 400 µg on sleep quality in COPD: A pilot study

Background: Aclidinium bromide 400 µg (AB) is known to improve lung function and symptoms in moderate to severe COPD; however, sleep disturbances are common in patients with COPD. Aim: This study investigated the effects of AB on symptoms and sleep quality. Methods: This was a Phase IV, 21-day, randomized, double-blind, placebo (PBO)-controlled, two-period, crossover pilot study (NCT02153489). Assessments included FEV 1 , symptoms (cough, wheeze, sputum, dyspnoea, chest tightness, congestion), physical activity, polysomnography and adverse events (AEs). Results: Patients (n=30; mean age: 64.4 y; male: 50%; mean pre-bronchodilator FEV 1 ±standard deviation: 1.3±0.4 L) received AB or PBO twice daily (BID). Patients with obstructive sleep apnoea were excluded. After 21 days, AB improved both trough and peak FEV 1 vs PBO (p Conclusions: In this pilot study, aclidinium 400 µg BID significantly improved lung function. Improvements were also observed in sleep quality, physical activity and symptoms in patients with moderate COPD. These changes may be clinically important and therefore require confirmation in adequately powered studies.