NCT00308191
Completed
Phase 3
A 6-Week Double-Blind, Parallel-Group, Active-Controlled Trial to Compare the Efficacy and Safety of Concomitant Treatment of Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obstructive Pulmonary Disease
Dey1 site in 1 country128 target enrollmentApril 2006
ConditionsCOPD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- Dey
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Measure of lung Function
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the concomitant treatment of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide alone.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Measure of lung Function
Secondary Outcomes
- Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires
Study Sites (1)
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