Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
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
| NCT number | NCT00106821 |
| Other study ID # | 205.294 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | March 31, 2005 |
| Last updated | October 31, 2013 |
| Start date | June 2004 |
| Verified date | October 2013 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 166 |
| Est. completion date | |
| Est. primary completion date | August 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
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: - Asthma - Recent myocardial infarction or hospitalization for congestive heart failure |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Boehringer Ingelheim Investigational Site | Birmingham | Alabama |
| United States | Cooper Green Hospital | Birmingham | Alabama |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Bronx VA Medical Center | Bronx | New York |
| United States | Boehringer Ingelheim Investigational Site | Charleston | South Carolina |
| United States | Brody School of Medicine, East Carolina University | Greenville | North Carolina |
| United States | Attention: Amir Sharafkhaneh, M.D. | Houston | Texas |
| United States | VAMC Houston | Houston | Texas |
| United States | David Geffen School of Medicine | Los Angeles | California |
| United States | Louisiana State University School of Medicine | New Orleans | Louisiana |
| United States | Emerald Coast Research Associates | Panama City | Florida |
| United States | Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania |
| United States | Temple University Hospital | Philadelphia | Pennsylvania |
| United States | VA Greater Los angeles Health Care Systems | Sepulveda | California |
| United States | LSU MC-Sheveport | Shreveport | Louisiana |
| United States | Spartanburg Medical Research | Spartanburg | South Carolina |
| United States | Bay Pines V. A. Medical Center | St. Petersberg | Florida |
| United States | Boehringer Ingelheim Investigational Site | Waterbury | Connecticut |
| United States | Yale Univ. Pulmonary and Critical Care Medicine | WEst Haven | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment | |||
| Secondary | 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 |
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