RT Journal Article
SR Electronic
T1 Improvement in COPD symptoms with aclidinium bromide vs placebo and tiotropium: A phase IIIb study
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 184
VO 42
IS Suppl 57
A1 Jutta Beier
A1 Anne-Marie Kirsten
A1 Robert Mróz
A1 Rosa Segarra
A1 Ferran Chuecos
A1 Cynthia Caracta
A1 Esther Garcia Gil
YR 2013
UL http://erj.ersjournals.com/content/42/Suppl_57/184.abstract
AB 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).View this table:Change from baseline (difference vs placebo) over 6 weeksConclusions: 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.