drugset / Trial / NCT01772134
Efficacy and Safety of the Addition of Fluticanse Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide (62.5 or 125mcg) Once-daily Over 12 Weeks
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.
Timeline
- Start
- 2013-01-01
- Primary completion
- 2013-07-01
- Completion
- 2013-07-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Umeclidinium | Other / unclassified | 62.5 ug | Inhaled |
| Comparator | Umeclidinium | Other / unclassified | 125 ug | Inhaled |
| Background | Fluticasone propionate | Other / unclassified | 250 ug | Inhaled |
| Background | Salmeterol | Other / unclassified | 50 ug | Inhaled |