The ATTAIN study: Bronchodilatory effect of aclidinium bromide in chronic obstructive pulmonary disease (COPD)

Abstract

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 AUC_0-3h 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 AUC_0-3h 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.