Tiotropium (18 Mcg) Once Daily Via the HandiHaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274547
First received: January 9, 2006
Last updated: October 31, 2013
Last verified: October 2013
  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 an 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 Veterans Affairs Setting

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percentage of patients experiencing an exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients hospitalized for a COPD exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first COPD exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Time to first hospitalization associated with an COPD exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Total number of days of corticosteroids for an COPD exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Total number of antibiotics for an COPD exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of unscheduled out-patient visits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Total number of hospital admissions and total hospital days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Trough post-dose FEV1 and FVC [ Time Frame: after 3 and 6 months ] [ Designated as safety issue: No ]
  • 90 minute post-dose FEV1 and FVC [ Time Frame: after 3 and 6 months ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 1829
Study Start Date: September 2001
Primary Completion Date: February 2003 (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
  Contacts and Locations
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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
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274547     History of Changes
Other Study ID Numbers: 205.266
Study First Received: January 9, 2006
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014