Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.

Summary

The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.

Timeline

Start

2010-05

Primary completion

2010-08

Completion

2010-08

Outcome

Met primary endpoint

paper After 7 days of treatment, aclidinium and formoterol produced statistically significantly greater changes from baseline in FEV1 normalised AUC0-12 vs placebo (p<0.0001). PMID 22497752 ↗

paper Improvements in primary and secondary endpoints were statistically significantly greater with aclidinium 400 μg vs 100 μg. PMID 22497752 ↗

Publications

• Singh D, Magnussen H, Kirsten A, Mindt S, Caracta C, Seoane B, Jarreta D, Garcia Gil E. A randomised, placebo- and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients. Pulm Pharmacol Ther. 2012 Jun;25(3):248-53. doi: 10.1016/j.pupt.2012.03.008. Epub 2012 Apr 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aclidinium	Unknown	100 ug	Inhaled
Subject	Aclidinium	Unknown	200 ug	Inhaled
Subject	Aclidinium	Unknown	400 ug	Inhaled
Comparator	Formoterol	Other / unclassified	12 ug	Inhaled

Indications