Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo
Summary
The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.
Timeline
- Start
- 2009-12
- Primary completion
- 2010-08
- Completion
- 2010-08
Outcome
Met primary endpoint
registry Aclidinium 400 μg / Formoterol 12 μg vs Placebo; p <0.0001; Least square mean difference 0.200 (95% CI 0.156 to 0.245) NCT01049360 ↗
registry Aclidinium 400 μg / Formoterol 6 μg vs Placebo; p <0.0001; Least square mean difference 0.202 (95% CI 0.158 to 0.245) NCT01049360 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclidinium | Unknown | 400 ug | — |
| Comparator | Formoterol | Other / unclassified | 6 ug | — |
| Comparator | Formoterol | Other / unclassified | 12 ug | — |