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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium Bromide Inhalation Powder | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |||
| Cooper Green Hospital |
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| 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 |
| Boehringer Ingelheim Investigational Site | Waterbury | Connecticut | 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 | Saint Petersberg | Florida | United States |
| Louisiana State University School of Medicine | New Orleans | Louisiana | United States |
| LSU MC-Sheveport | Shreveport | Louisiana | United States |
| Bronx VA Medical Center | The Bronx | New York | United States |
| Brody School of Medicine, East Carolina University | Greenville | North Carolina | United States |
| Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | United States |
| Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | United States |
| Attention: Amir Sharafkhaneh, M.D. | Houston | Texas | United States |
| VAMC Houston | Houston | Texas | United States |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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