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

NCT ID: NCT00274547

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1829 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Brief Summary

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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

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tiotropium

Intervention Type DRUG

Eligibility Criteria

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Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

Carl T. Hayden VA Medical Center

Phoenix, Arizona, United States

Site Status

Southern Arizona VA Health Care System

Tuscon, Arizona, United States

Site Status

VA Long Beach Healthcare System

Long Beach, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Palo Alto, California, United States

Site Status

Respiratory Diseases (111A)

Bay Pines, Florida, United States

Site Status

J. Hillis Miller Health Center

Gainesville, Florida, United States

Site Status

Veteran Affairs Medical Center

Hines, Illinois, United States

Site Status

Veterans Affairs Medical Center

North Chicago, Illinois, United States

Site Status

Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Site Status

Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Site Status

4720 I-10 Service Road

Metairie, Louisiana, United States

Site Status

Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Site Status

Veteran Affairs Medical Center

Minneapolis, Minnesota, United States

Site Status

Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Site Status

Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Site Status

Boehringer Ingelheim Investigational Site

Reno, Nevada, United States

Site Status

Boehringer Ingelheim Investigational Site

Buffalo, New York, United States

Site Status

Bronx VA Medical Center

New York, New York, United States

Site Status

Boehringer Ingelheim Investigational Site

Durham, North Carolina, United States

Site Status

Dallas VAMC

Dallas, Texas, United States

Site Status

Veterans Affairs Medical Center

Houston, Texas, United States

Site Status

Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Site Status

Hampton VA Medical Center

Hampton, Virginia, United States

Site Status

Hunter Holmes McGuire Medical Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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205.266

Identifier Type: -

Identifier Source: org_study_id