TY - JOUR T1 - The effect of aclidinium bromide 400 µg on sleep quality in COPD: A pilot study JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.congress-2016.PA4051 VL - 48 IS - suppl 60 SP - PA4051 AU - Helgo Magnussen AU - Michael Arzt AU - Stefan Andreas AU - Tanja Plate AU - Anna Ribera AU - Beatriz Seoane AU - Henrik Watz AU - Anne-Marie Kirsten Y1 - 2016/09/01 UR - http://erj.ersjournals.com/content/48/suppl_60/PA4051.abstract N2 - 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 FEV1, 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 FEV1 ±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 FEV1 vs PBO (p<0.05). AB improved evening symptoms (p<0.01) vs PBO and showed numerical improvements in morning (p=0.06) and nighttime (p=0.08) symptoms. AB increased rapid eye movement sleep by 2.53% (p<0.05) and decreased oxygen desaturation index by 2.5 (p<0.05) vs PBO. AB numerically improved total sleep time by 19 min (p=0.11), sleep efficiency by 3.6% (p=0.12), moderate physical activity by 18 min/day (p=0.06) and number of steps by 246 steps/day (p=0.59) vs PBO. AEs were similar across groups; the most frequent were erythema (10.0%), nasopharyngitis (6.7%) and rhinitis (6.7%).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. ER -