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

Tracking Information

First Received Date ^ICMJE

January 9, 2006

Last Updated Date

May 14, 2012

Start Date ^ICMJE

September 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00274547 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Disease, Chronic Obstructive

Intervention ^ICMJE

Drug: Tiotropium

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1800

Completion Date

December 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Not Provided

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00274547

Other Study ID Numbers ^ICMJE

205.266

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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