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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00106821
First Posted: April 1, 2005
Last Update Posted: November 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  Purpose
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.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive Drug: Tiotropium Bromide Inhalation Powder Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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

Enrollment: 166
Study Start Date: June 2004
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106821


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

ClinicalTrials.gov Identifier: NCT00106821     History of Changes
Other Study ID Numbers: 205.294
First Submitted: March 31, 2005
First Posted: April 1, 2005
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Tiotropium Bromide
Bromides
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants