drugset / Trial / NCT01078623

Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate

NCT01078623

Phase 2 Completed 176 enrolled AstraZeneca
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD. Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.

Timeline

Start
2010-02
Primary completion
2010-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Aclidinium Small molecule 200 ug
Comparator Formoterol Other / unclassified 6 ug
Comparator Formoterol Other / unclassified 12 ug