Abstract
Background: The efficacy and safety of aclidinium bromide vs tiotropium and placebo in COPD has been evaluated in a randomized, double-blind, Phase IIIb study.
Aim: To report additional endpoints capturing the effect of treatment on COPD daily symptoms.
Methods: 414 patients with COPD (FEV1 1.6 L; 56% predicted) received aclidinium bromide 400 µg BID (metered dose; equivalent to aclidinium 322 µg delivered dose), tiotropium 18 µg QD or placebo for 6 weeks. Symptoms were assessed daily with the EXACT-Respiratory Symptoms (E-RS) and COPD additional symptoms questionnaires. Relief medication use was assessed.
Results: Results are summarized (Table).
Conclusions: Aclidinium provides significant COPD daily symptom improvement vs placebo, including less severe early-morning and night-time symptoms, and a greater number of relief medication-free days. Improvements were consistently numerically greater with aclidinium vs tiotropium.
- © 2013 ERS