A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD
Phase 3
Completed
- Conditions
- COPD
- Registration Number
- NCT00308191
- Lead Sponsor
- Dey
- 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.
- 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 Measure of lung Function
- Secondary Outcome Measures
Name Time Method Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the bronchodilatory effects of formoterol fumarate and tiotropium in COPD?
How does the combination of formoterol and tiotropium compare to standard-of-care long-acting beta agonists and anticholinergics in COPD patients?
Are there specific biomarkers that predict enhanced therapeutic response to combined formoterol and tiotropium treatment in COPD?
What are the potential adverse events associated with dual bronchodilation using formoterol and tiotropium in COPD patients?
How does the formoterol-tiotropium combination compare to other dual bronchodilator therapies like indacaterol-glycopyrronium in COPD management?
Trial Locations
- Locations (1)
Research Site
🇺🇸San Antonio, Texas, United States
Research Site🇺🇸San Antonio, Texas, United States