Efficacy of Tiotropium in Patients of African Descent With Chronic Obstructive Pulmonary Disease
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
1 other identifier
interventional
166
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 31, 2005
CompletedFirst Posted
Study publicly available on registry
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedNovember 1, 2013
October 1, 2013
1.2 years
March 31, 2005
October 31, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- Male or female of African descent
- 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
You may not qualify if:
- Asthma
- Recent myocardial infarction or hospitalization for congestive heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Boehringer Ingelheim Investigational Site
Birmingham, Alabama, 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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 31, 2005
First Posted
April 1, 2005
Study Start
June 1, 2004
Primary Completion
August 1, 2005
Last Updated
November 1, 2013
Record last verified: 2013-10