Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

Phase 2 Completed 30 enrolled AstraZeneca

RandomizedCrossoverDouble-blindTreatment

Summary

The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.

Timeline

Start: 2009-03
Primary completion: 2009-07
Completion: 2009-07

Outcome

Met primary endpoint

paper Mean change from baseline in FEV(1) AUC(0-12/12h) at day 15 was significantly greater for aclidinium and tiotropium over placebo (P < .0001). PMID 21903737 ↗

Publications

Fuhr R, Magnussen H, Sarem K, Llovera AR, Kirsten AM, Falques M, Caracta CF, Garcia Gil E. Efficacy of aclidinium bromide 400 mug twice daily compared with placebo and tiotropium in patients with moderate to severe COPD. Chest. 2012 Mar;141(3):745-752. doi: 10.1378/chest.11-0406. Epub 2011 Sep 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aclidinium	Unknown	400 ug	Inhaled
Comparator	Tiotropium	Other / unclassified	18 ug	Inhaled