TY - JOUR T1 - Efficacy and safety of aclidinium bromide vs placebo and tiotropium in COPD: A phase IIIb study JF - European Respiratory Journal JO - Eur Respir J VL - 42 IS - Suppl 57 SP - 185 AU - Jutta Beier AU - Anne-Marie Kirsten AU - Robert Mróz AU - Rosa Segarra AU - Ferran Chuecos AU - Cynthia Caracta AU - Esther Garcia Gil Y1 - 2013/09/01 UR - http://erj.ersjournals.com/content/42/Suppl_57/185.abstract N2 - Background: Maintaining significant bronchodilation throughout the entire day is important to improve COPD outcomes.Aim: To evaluate the 24-hour bronchodilatory efficacy and safety of aclidinium bromide vs tiotropium and placebo.Methods: In this randomized, double-blind study, 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) via Genuair®a, tiotropium 18 µg QD via HandiHaler® or placebo for 6 weeks. Endpoints included change from baseline in normalized FEV1 AUC0-24 (primary) and FEV1 AUC12-24 at Week 6, inhaler preference and safety.Results: Spirometry findings are summarized (Table). Genuair was preferred over HandiHaler (80% vs 11%; p<0.001). Patients were more willing to continue using Genuair than HandiHaler (89 vs 45; p<0.001 [0=not willing; 100=definitely willing]). AE incidence (28%, overall) was similar across groups. Few anticholinergic AEs (<2%) or SAEs (<3%) occurred in any group.View this table:Change from baseline (difference from placebo), mLConclusions: Aclidinium provided significant 24-hour bronchodilation vs placebo. Aclidinium and tiotropium had comparable efficacy after 6 weeks.aRegistered trademark of Almirall S.A., Barcelona, Spain, for use within the EU, Iceland and Norway as Genuair®, and within the USA as PressairTM. ER -