RT Journal Article
SR Electronic
T1 Efficacy and safety of twice-daily aclidinium bromide in COPD patients: The ATTAIN study
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP erj02255-2011
DO 10.1183/09031936.00225511
A1 Paul W. Jones
A1 Dave Singh
A1 Eric D. Bateman
A1 Alvar Agusti
A1 Rosa Lamarca
A1 Gonzalo de Miquel
A1 Rosa Segarra
A1 Cynthia Caracta
A1 Esther Garcia Gil
YR 2012
UL http://erj.ersjournals.com/content/early/2012/03/22/09031936.00225511.abstract
AB The efficacy and safety of two doses of aclidinium bromide were evaluated in patients with moderate to severe COPD.In this 24-week, double-blind trial, patients were randomised to twice-daily aclidinium (200 μg or 400 μg) or placebo. The primary efficacy endpoint was change in trough forced expiratory volume in 1 second (FEV1) at Week 24. Other endpoints included peak FEV1, health status (St George's Respiratory Questionnaire; SGRQ) and dyspnoea (Transitional Dyspnoea Index; TDI).Overall, 828 patients were randomised. At Week 24, significant improvements from baseline were observed with aclidinium 200 μg and 400 μg versus placebo for trough FEV1 (99 and 128 mL; both p<0.0001) and peak FEV1 (185 and 209 mL; both p<0.0001). Peak FEV1 improvements on Day 1 were comparable with Week 24. Aclidinium 200 μg and 400 μg produced significant improvements over placebo in baseline-adjusted mean SGRQ total score (−3.8 and −4.6 units; p<0.001 and <0.0001) and TDI focal score (0.6 and 1.0 units; p<0.05 and <0.001) at Week 24. With both aclidinium doses, the incidence of anticholinergic adverse events was low and similar to placebo.Twice-daily aclidinium significantly improved bronchodilation, health status and dyspnoea, and was well tolerated in patients with COPD.