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

This study has been completed.
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
First received: January 9, 2006
Last updated: October 31, 2013
Last verified: October 2013
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)

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

  Show 26 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
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:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2015