Efficacy of Tiotropium in Patients of African Descent With Chronic Obstructive Pulmonary Disease
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00106821
First received: March 31, 2005
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: Tiotropium Bromide Inhalation Powder |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Tiotropium bromide
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 180 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | January 2006 |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106821
Locations
| United States, Alabama | |
| Boehringer Ingelheim Investigational Site | |
| Birmingham, Alabama, United States | |
| Cooper Green Hospital | |
| Birmingham, Alabama, United States | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States | |
| United States, California | |
| David Geffen School of Medicine | |
| Los Angeles, California, United States | |
| VA Greater Los angeles Health Care Systems | |
| Sepulveda, California, United States | |
| United States, Connecticut | |
| Boehringer Ingelheim Investigational Site | |
| Waterbury, Connecticut, United States | |
| Yale Univ. Pulmonary and Critical Care Medicine | |
| WEst Haven, Connecticut, United States | |
| United States, Florida | |
| Emerald Coast Research Associates | |
| Panama City, Florida, United States | |
| Bay Pines V. A. Medical Center | |
| St. Petersberg, Florida, United States | |
| United States, Louisiana | |
| Louisiana State University School of Medicine | |
| New Orleans, Louisiana, United States | |
| LSU MC-Sheveport | |
| Shreveport, Louisiana, United States | |
| United States, New York | |
| Bronx VA Medical Center | |
| Bronx, New York, United States | |
| United States, North Carolina | |
| Brody School of Medicine, East Carolina University | |
| Greenville, North Carolina, United States | |
| United States, Pennsylvania | |
| Boehringer Ingelheim Investigational Site | |
| Philadelphia, Pennsylvania, United States | |
| Temple University Hospital | |
| Philadelphia, Pennsylvania, United States | |
| United States, South Carolina | |
| Boehringer Ingelheim Investigational Site | |
| Charleston, South Carolina, United States | |
| Spartanburg Medical Research | |
| Spartanburg, South Carolina, United States | |
| United States, Texas | |
| Attention: Amir Sharafkhaneh, M.D. | |
| Houston, Texas, United States | |
| VAMC Houston | |
| Houston, Texas, United States | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00106821 History of Changes |
| Other Study ID Numbers: | 205.294 |
| Study First Received: | March 31, 2005 |
| Last Updated: | May 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Tiotropium Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013