drugset / Trial / NCT00784550
A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH \& Co. KG. ADVAIR DISKUS® are registered trademarks of the GSK group of companies.
Timeline
- Start
- 2008-12
- Primary completion
- 2009-12
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone propionate | Other / unclassified | 250 ug | Inhaled |
| Subject | Salmeterol | Other / unclassified | 50 ug | Inhaled |
| Comparator | Tiotropium | Other / unclassified | 18 ug | Inhaled |