Clinical trial NCT00106821: Efficacy of Tiotropium in Patients of African Descent With Chronic Obstructive Pulmonary Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-04-01
Enrollment: 166
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Cooper Green Hospital
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: David Geffen School of Medicine
state: California
city: Sepulveda
country: United States
facility: VA Greater Los angeles Health Care Systems
state: California
city: Waterbury
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Connecticut
city: WEst Haven
country: United States
facility: Yale Univ. Pulmonary and Critical Care Medicine
state: Connecticut
city: Panama City
country: United States
facility: Emerald Coast Research Associates
state: Florida
city: St. Petersberg
country: United States
facility: Bay Pines V. A. Medical Center
state: Florida
city: New Orleans
country: United States
facility: Louisiana State University School of Medicine
state: Louisiana
city: Shreveport
country: United States
facility: LSU MC-Sheveport
state: Louisiana
city: Bronx
country: United States
facility: Bronx VA Medical Center
state: New York
city: Greenville
country: United States
facility: Brody School of Medicine, East Carolina University
state: North Carolina
city: Philadelphia
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Houston
country: United States
facility: Attention: Amir Sharafkhaneh, M.D.
state: Texas
city: Houston
country: United States
facility: VAMC Houston
state: Texas
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: