Improvement in symptoms and rescue medication use with aclidinium bromide in patients with chronic obstructive pulmonary disease: Results from ATTAIN

Abstract

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, 828 patients were randomised (1:1:1) to twice-daily aclidinium (200 μg or 400 μg) or placebo. COPD symptoms were assessed using the Transitional Dyspnoea Index (TDI), patient-reported daily electronic diaries and Total Exact score. Reliever medication use was also assessed.

Results: Baseline characteristics were similar between the groups; FEV₁% predicted 56.8±12.8%, focal BDI 6.8±2.1. More patients treated with aclidinium 200 μg or 400 μg had a clinically meaningful improvement in TDI focal score (≥1 unit) vs placebo at Week 24 (53.3% and 56.9% vs 45.5%; p=0.032 and 0.004, respectively). Aclidinium dose-dependently improved TDI focal score at Week 24, which was clinically meaningful for aclidinium 400 μg (1.0 unit) and statistically significant for both doses vs placebo (200 μg, p<0.05; 400 μg, p<0.001). Over the study period, aclidinium (both doses) was associated with a lower incidence of night-time (p<0.0001) and early-morning (p<0.01) COPD symptoms, a greater reduction in Total Exact score (p≤0.0001) and more days without reliever medication (p=0.0003) vs placebo.

Conclusions: Aclidinium 200 μg and 400 μg twice-daily provided statistically significant and clinically meaningful improvements in COPD symptoms in patients with moderate to severe COPD.

This study was supported by Almirall S.A., Barcelona, Spain, and Forest Laboratories, Inc, New York, USA.