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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tiotropium Bromide Inhalation Powder
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boehringer Ingelheim Investigational Site
  • Cooper Green Hospital
  • University of Alabama at Birmingham
  • David Geffen School of Medicine
  • VA Greater Los angeles Health Care Systems
  • Boehringer Ingelheim Investigational Site
  • Yale Univ. Pulmonary and Critical Care Medicine
  • Emerald Coast Research Associates
  • Bay Pines V. A. Medical Center
  • Louisiana State University School of Medicine
  • LSU MC-Sheveport
  • Bronx VA Medical Center
  • Brody School of Medicine, East Carolina University
  • Boehringer Ingelheim Investigational Site
  • Temple University Hospital
  • Boehringer Ingelheim Investigational Site
  • Spartanburg Medical Research
  • Attention: Amir Sharafkhaneh, M.D.
  • VAMC Houston

Outcomes

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

Full Information

First Posted
March 31, 2005
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00106821
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tiotropium Bromide Inhalation Powder
Primary Outcome Measure Information:
Title
The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Cooper Green Hospital
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
David Geffen School of Medicine
City
Los Angeles
State/Province
California
Country
United States
Facility Name
VA Greater Los angeles Health Care Systems
City
Sepulveda
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
Yale Univ. Pulmonary and Critical Care Medicine
City
WEst Haven
State/Province
Connecticut
Country
United States
Facility Name
Emerald Coast Research Associates
City
Panama City
State/Province
Florida
Country
United States
Facility Name
Bay Pines V. A. Medical Center
City
St. Petersberg
State/Province
Florida
Country
United States
Facility Name
Louisiana State University School of Medicine
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
LSU MC-Sheveport
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Bronx VA Medical Center
City
Bronx
State/Province
New York
Country
United States
Facility Name
Brody School of Medicine, East Carolina University
City
Greenville
State/Province
North Carolina
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Attention: Amir Sharafkhaneh, M.D.
City
Houston
State/Province
Texas
Country
United States
Facility Name
VAMC Houston
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.294_U06-3041.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.294_literature.pdf
Description
Related Info

Learn more about this trial

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

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