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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00274547
First Posted: January 11, 2006
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 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
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 ]
  • Percentage of patients hospitalized for a COPD exacerbation [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Time to first COPD exacerbation [ Time Frame: 6 months ]
  • Time to first hospitalization associated with an COPD exacerbation [ Time Frame: 6 months ]
  • Total number of days of corticosteroids for an COPD exacerbation [ Time Frame: 6 months ]
  • Total number of antibiotics for an COPD exacerbation [ Time Frame: 6 months ]
  • Number of unscheduled out-patient visits [ Time Frame: 6 months ]
  • Total number of hospital admissions and total hospital days [ Time Frame: 6 months ]
  • Trough post-dose FEV1 and FVC [ Time Frame: after 3 and 6 months ]
  • 90 minute post-dose FEV1 and FVC [ Time Frame: after 3 and 6 months ]
  • Occurrence of serious adverse events [ Time Frame: 6 months ]

Enrollment: 1829
Study Start Date: September 2001
Primary Completion Date: February 2003 (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
  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): NCT00274547


  Show 26 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

ClinicalTrials.gov Identifier: NCT00274547     History of Changes
Other Study ID Numbers: 205.266
First Submitted: January 9, 2006
First Posted: January 11, 2006
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Tiotropium Bromide
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