Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate
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
Outcome
Met primary endpoint
registry Placebo vs Aclidinium 200 μg / Formoterol 12 μg; p <0.0001; Least squares mean difference 0.221 (95% CI 0.174 to 0.268); Mixed Models Analysis NCT01078623 ↗
registry Placebo vs Aclidinium 200 μg / Formoterol 6 μg; p <0.0001; Least squares mean difference 0.234 (95% CI 0.186 to 0.281); Mixed Models Analysis NCT01078623 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclidinium | Unknown | 200 ug | — |
| Comparator | Formoterol | Other / unclassified | 6 ug | — |
| Comparator | Formoterol | Other / unclassified | 12 ug | — |