RT Journal Article
SR Electronic
T1 The effect of aclidinium bromide 400 µg on sleep quality in COPD: A pilot study
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP PA4051
DO 10.1183/13993003.congress-2016.PA4051
VO 48
IS suppl 60
A1 Helgo Magnussen
A1 Michael Arzt
A1 Stefan Andreas
A1 Tanja Plate
A1 Anna Ribera
A1 Beatriz Seoane
A1 Henrik Watz
A1 Anne-Marie Kirsten
YR 2016
UL http://erj.ersjournals.com/content/48/suppl_60/PA4051.abstract
AB 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.