RT Journal Article
SR Electronic
T1 The ATTAIN study: Bronchodilatory effect of aclidinium bromide in chronic obstructive pulmonary disease (COPD)
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP p875
VO 38
IS Suppl 55
A1 David Singh
A1 Eric D. Bateman
A1 Paul W. Jones
A1 Alvar Agusti
A1 Rosa Lamarca
A1 Gonzalo de Miquel
A1 Cynthia Caracta
A1 Esther Garcia Gil
YR 2011
UL http://erj.ersjournals.com/content/38/Suppl_55/p875.abstract
AB Introduction: Aclidinium bromide is a long-acting muscarinic antagonist in clinical development for the treatment of COPD.Aims: To assess the bronchodilatory effect of aclidinium 200 μg and 400 μg in patients with COPD.Methods: In this 24-week, double-blind, Phase III study (NCT01001494), patients were randomised to aclidinium 200 μg, 400 μg or placebo BID. The primary endpoint was change from baseline in trough FEV1 at Week 24. Other endpoints included: trough response over time; change from baseline in peak FEV1; time to peak FEV1 and normalised AUC0-3h FEV1.Results: A total of 828 patients were randomised and 737 (89.0%) patients completed the study. Aclidinium 200 μg and 400 μg significantly improved trough FEV1 vs placebo; these improvements were maintained throughout the 6-month treatment period. At Week 24, increases in trough FEV1 from baseline vs placebo for aclidinium 200 μg and 400 μg were 99 mL and 128 mL, respectively (both p<0.0001). Aclidinium 200 μg and 400 μg increased peak FEV1 vs placebo (185 mL and 209 mL, respectively; both p<0.0001). Time to peak FEV1 was ≤2 h post-dose (aclidinium 200 μg, 108 min; aclidinium 400 μg, 100 min). Aclidinium 200 μg and 400 μg significantly improved normalised AUC0-3h FEV1 vs placebo at Week 24 (183 mL and 210 mL, respectively; both p<0.0001).Conclusions: Aclidinium 200 μg and 400 μg twice-daily significantly improved bronchodilation in patients with moderate to severe COPD.This study was supported by Almirall S.A., Barcelona, Spain, and Forest Laboratories, Inc, New York, USA.