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

October 31, 2013 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States
        • Cooper Green Hospital
      • Birmingham, Alabama, United States
        • Boehringer Ingelheim Investigational Site
    • California
      • Los Angeles, California, United States
        • David Geffen School of Medicine
      • Sepulveda, California, United States
        • VA Greater Los angeles Health Care Systems
    • Connecticut
      • WEst Haven, Connecticut, United States
        • Yale Univ. Pulmonary and Critical Care Medicine
      • Waterbury, Connecticut, United States
        • Boehringer Ingelheim Investigational Site
    • Florida
      • Panama City, Florida, United States
        • Emerald Coast Research Associates
      • St. Petersberg, Florida, United States
        • Bay Pines V. A. Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States
        • Louisiana State University School of Medicine
      • Shreveport, Louisiana, United States
        • LSU MC-Sheveport
    • New York
      • Bronx, New York, United States
        • Bronx VA Medical Center
    • North Carolina
      • Greenville, North Carolina, United States
        • Brody School of Medicine, East Carolina University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States
        • Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Boehringer Ingelheim Investigational Site
      • Spartanburg, South Carolina, United States
        • Spartanburg Medical Research
    • Texas
      • Houston, Texas, United States
        • Attention: Amir Sharafkhaneh, M.D.
      • Houston, Texas, United States
        • VAMC Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

March 31, 2005

First Submitted That Met QC Criteria

March 31, 2005

First Posted (Estimate)

April 1, 2005

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.294

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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