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

October 31, 2013 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Intervention / Treatment

Drug: Tiotropium

Study Type

Interventional

Enrollment (Actual)

1829

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients experiencing an exacerbation Time Frame: 6 months	6 months
Percentage of patients hospitalized for a COPD exacerbation Time Frame: 6 months	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

January 9, 2006

First Submitted That Met QC Criteria