Efficacy of Tiotropium in Patients of African Descent With Chronic Obstructive Pulmonary Disease
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00106821
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
- 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
- Asthma
- Recent myocardial infarction or hospitalization for congestive heart failure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (16)
Boehringer Ingelheim Investigational Site
🇺🇸Charleston, South Carolina, United States
Cooper Green Hospital
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
David Geffen School of Medicine
🇺🇸Los Angeles, California, United States
VA Greater Los angeles Health Care Systems
🇺🇸Sepulveda, California, United States
Yale Univ. Pulmonary and Critical Care Medicine
🇺🇸WEst Haven, Connecticut, United States
Emerald Coast Research Associates
🇺🇸Panama City, Florida, United States
Bay Pines V. A. Medical Center
🇺🇸St. Petersberg, Florida, United States
Louisiana State University School of Medicine
🇺🇸New Orleans, Louisiana, United States
LSU MC-Sheveport
🇺🇸Shreveport, Louisiana, United States
Scroll for more (6 remaining)Boehringer Ingelheim Investigational Site🇺🇸Charleston, South Carolina, United States