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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00106821
First received: March 31, 2005
Last updated: October 31, 2013
Last verified: October 2013
  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-Blind
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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Temple University Hospital
Philadelphia, Pennsylvania, United States
Boehringer Ingelheim Investigational Site
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00106821     History of Changes
Other Study ID Numbers: 205.294
Study First Received: March 31, 2005
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014