NCT00106821CompletedPhase 4
An 8 Week Randomized, Placebo Controlled, Double-blind Study to Assess the Efficacy of Tiotropium Inhalation Capsules in Patients of African Descent With Chronic Obstructive Pulmonary Disease
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 166
- Locations
- 22
- Primary Endpoint
- The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment
Study Overview
Brief Summary
The purpose of this study is to look at the benefits of tiotropium, an approved drug for the treatment of bronchospasm associated with COPD (chronic obstructive pulmonary disease), in a population of patients with COPD who are of African American descent.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female of African descent
- •40 years of age or older
- •Diagnosis of COPD
- •History of smoking at least one pack per day for at least 10 years
- •Currently experiencing shortness of breath at least with exertion
Exclusion Criteria
- •Recent myocardial infarction or hospitalization for congestive heart failure
Outcomes
Primary Outcomes
The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment
Secondary Outcomes
- FEV1 AUC0-3 after single dose, 4 weeks of treatment, peak FEV1 on each test day, trough FEV1 at weeks 4 & 8, FVC trough (weeks 4 & 8), peak and AUC(0-3) (on all test days), FEV1 and FVC at all time points, rescue albuterol use, dyspnea SOP questionnaire
Investigators
Study Sites (22)
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