Study in Subjects Greater Than 40 Years of Age With COPD
Phase 3
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT00507234
- Lead Sponsor
- Dey
- Brief Summary
This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled, parallel-group, comparative study.
The objectives of this study are:
1. To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.
2. To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice daily compared to tiotropium 18 mcg once daily.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
Inclusion Criteria
- Medical diagnosis of COPD
- Current or prior history of cigarette smoking
Exclusion Criteria
- Medical diagnosis of asthma
- Significant condition or disease other than COPD
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint will be the standardized area under the curve for FEV1 (FEV1 AUC0-3) over the 3-hour assessment period at End Study (Week 6/ET). 6 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Site
🇺🇸Milwaukee, Wisconsin, United States