Efficacy of Tiotropium in Patients of African Descent With Chronic Obstructive Pulmonary Disease

NCT ID: NCT00106821

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tiotropium Bromide Inhalation Powder

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

Cooper Green Hospital

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

David Geffen School of Medicine

Los Angeles, California, United States

Site Status

VA Greater Los angeles Health Care Systems

Sepulveda, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Site Status

Yale Univ. Pulmonary and Critical Care Medicine

West Haven, Connecticut, United States

Site Status

Emerald Coast Research Associates

Panama City, Florida, United States

Site Status

Bay Pines V. A. Medical Center

Saint Petersberg, Florida, United States

Site Status

Louisiana State University School of Medicine

New Orleans, Louisiana, United States

Site Status

LSU MC-Sheveport

Shreveport, Louisiana, United States

Site Status

Bronx VA Medical Center

The Bronx, New York, United States

Site Status

Brody School of Medicine, East Carolina University

Greenville, North Carolina, United States

Site Status

Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Site Status

Attention: Amir Sharafkhaneh, M.D.

Houston, Texas, United States

Site Status

VAMC Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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205.294

Identifier Type: -

Identifier Source: org_study_id