Trials / Completed
CompletedNCT00424528
Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)
A Two-Week, Randomized, Modified-Blind, Double-Dummy, Parallel-Group Efficacy and Safety Study of Arformoterol Tartrate Inhalation Solution Twice-Daily, Tiotropium Once-Daily, and Arformoterol Tartrate Inhalation Solution Twice-Daily and Tiotropium Once Daily in Subjects With Chronic Obstructive Pulmonary Disease
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 235 (actual)
- Sponsor
- Sumitomo Pharma America, Inc. · Industry
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).
Detailed description
This study is a multicenter, randomized, modified-blind, double-dummy two-week parallel-group efficacy and safety study of arformoterol tartrate inhalation solution twice daily, tiotropium inhalation powder once daily and arformoterol tartrate inhalation solution twice daily and tiotropium inhalation powder once daily (dosed sequentially) in subjects with COPD. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Arformoterol Tartrate Inhalation Solution | Arformoterol tartrate inhalation solution 15 mcg twice daily and placebo inhalation powder once daily. |
| DRUG | Tiotropium | Placebo inhalation solution twice daily and tiotropium inhalation powder 18 mcg once daily. |
| DRUG | Arformoterol and Tiotropium | Arformoterol tartrate inhalation solution 15 mcg twice daily and Tiotropium inhalation powder 18 mcg once daily. |
| DRUG | Placebo | Placebo inhalation solution and placebo inhalation powder |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2007-10-01
- Completion
- 2007-10-01
- First posted
- 2007-01-19
- Last updated
- 2012-06-04
- Results posted
- 2009-04-02
Locations
28 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00424528. Inclusion in this directory is not an endorsement.