RT Journal Article
SR Electronic
T1 Aclidinium bromide in patients with chronic obstructive pulmonary disease: Improvement in health status in ATTAIN
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP p877
VO 38
IS Suppl 55
A1 Paul W. Jones
A1 Alvar Agusti
A1 Eric D. Bateman
A1 David Singh
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/p877.abstract
AB Introduction: The ATTAIN study investigated the efficacy and safety of two twice-daily doses of aclidinium bromide, a long-acting muscarinic antagonist, in patients with moderate to severe chronic obstructive pulmonary disease (COPD).Methods: In this 24-week, double-blind trial, patients were randomised (1:1:1) to receive aclidinium (200 μg or 400 μg) or placebo, twice-daily. Health status was assessed using the St George's Respiratory Questionnaire (SGRQ) and the EuroQol Questionnaire (EQ-5D; both the weighted health status index and the visual analogue scale [VAS]).Results: There were 819 patients in the intent-to-treat population; forced expiratory volume in 1 second [FEV1%] predicted 56.8±12.8%, baseline SGRQ total score 46.3±16.8 units. At Week 24, more patients had a clinically significant improvement in SGRQ total score (decrease of ≥4 units) with aclidinium 200 μg and 400 μg than placebo (54.9% and 54.3% vs 39.5%; p=0.0004 and 0.0014, respectively). At Week 24, the improvement with aclidinium 400 μg was 4.3 units, p<0.0001. SGRQ domain scores (Symptoms, Activity, Impacts) were also significantly improved with both doses vs placebo at Week 24 (p<0.05 all domains). Aclidinium 200 μg and 400 μg also improved the EQ-5D weighted index and VAS compared with placebo at Week 24; the 400 μg dose reached statistical significance for the weighted index (p=0.041) and VAS (p=0.005) vs placebo.Conclusions: Aclidinium 200 μg and 400 μg twice-daily provided statistically and clinically significant improvements in health status.This study was supported by Almirall S.A., Barcelona, Spain, and Forest Laboratories, Inc, New York, USA.