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Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) in the Veterans Affairs (VA) Setting

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00274547
First received: January 9, 2006
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  Purpose

The primary objective of this trial is to determine whether treatment with tiotropium (18 mcg) capsule once daily via the HandiHaler reduces the proportion of patients with COPD experiencing an exacerbation and the proportion of patients hospitalized for an exacerbation during a six month observation period.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Drug: Tiotropium
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel, Group Trial Assessing the Proportion of Patients Experiencing Exacerbation and Proportion of Patients Hospitalized for an Exacerbation Over 6 Months During Treatment With Tiotropium 18 Mcg Capsule Once Daily in Patients With COPD in a VA Setting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The co-primary endpoints were the proportion of patients experiencing an exacerbation of COPD and the proportion of patients hospitalized for a COPD exacerbation during the six month treatment period.

Secondary Outcome Measures:
  • Number of exacerbations and related hospitalizations, time to first exacerbation and related hospitalization, mean # of days of antibiotics/steroids for exacerbations, # of unscheduled visits for exacerbation, pulmonary function at study visits.

Estimated Enrollment: 1800
Study Start Date: September 2001
Estimated Study Completion Date: December 2003
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274547

  Hide Study Locations
Locations
United States, Alabama
Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, Arizona
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States
Southern Arizona VA Health Care System
Tuscon, Arizona, United States
United States, California
VA Long Beach Healthcare System
Long Beach, California, United States
Boehringer Ingelheim Investigational Site
Palo Alto, California, United States
United States, Florida
Respiratory Diseases (111A)
Bay Pines, Florida, United States
J. Hillis Miller Health Center
Gainesville, Florida, United States
United States, Illinois
Veteran Affairs Medical Center
Hines, Illinois, United States
Veterans Affairs Medical Center
North Chicago, Illinois, United States
United States, Indiana
Boehringer Ingelheim Investigational Site
Indianapolis, Indiana, United States
United States, Kentucky
Boehringer Ingelheim Investigational Site
Lexington, Kentucky, United States
United States, Louisiana
4720 I-10 Service Road
Metairie, Louisiana, United States
United States, Massachusetts
Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
United States, Minnesota
Veteran Affairs Medical Center
Minneapolis, Minnesota, United States
United States, Missouri
Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
United States, Nebraska
Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
United States, Nevada
Boehringer Ingelheim Investigational Site
Reno, Nevada, United States
United States, New York
Boehringer Ingelheim Investigational Site
Buffalo, New York, United States
Bronx VA Medical Center
New York, New York, United States
United States, North Carolina
Boehringer Ingelheim Investigational Site
Durham, North Carolina, United States
United States, Texas
Dallas VAMC
Dallas, Texas, United States
Veterans Affairs Medical Center
Houston, Texas, United States
Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
United States, Utah
Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
United States, Virginia
Hampton VA Medical Center
Hampton, Virginia, United States
Hunter Holmes McGuire Medical Center
Richmond, Virginia, United States
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00274547     History of Changes
Other Study ID Numbers: 205.266
Study First Received: January 9, 2006
Last Updated: May 14, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013