12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD

NCT ID: NCT00240435

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

491 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler

Intervention Type DEVICE

10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Outpatients of either sex, aged \>/= 40 years with a diagnosis of COPD (FEV1 \</= 60% predicted \[ECCS criteria\] and FEV1/FVC \</= 70%)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

Boehringer Ingelheim Investigational Site

Downey, California, United States

Site Status

University of California - Los Angeles

Los Angeles, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Palo Alto, California, United States

Site Status

Rocky Mountain Center for Clinical Research

Wheat Ridge, Colorado, United States

Site Status

Boehringer Ingelheim Investigational Site

Bay Pines, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Wheaton, Maryland, United States

Site Status

Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

Boehringer Ingelheim Investigational Site

New Hyde Park, New York, United States

Site Status

Boehringer Ingelheim Investigational Site

Elizabeth City, North Carolina, United States

Site Status

Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Site Status

Boehringer Ingelheim Investigational Site

Courtice, Ontario, Canada

Site Status

St. Joseph's Hospital Cardiac Research

Hamilton, Ontario, Canada

Site Status

Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

Department of Respiratory Medicine

Toronto, Ontario, Canada

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

SMBD--Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Centre de Recherche Clinique -CUSE

Sherbrooke, Quebec, Canada

Site Status

Hopital Laval

Ste-Foy, Quebec, Canada

Site Status

c/o Hemodynamics Offices

Saskatoon, Saskatchewan, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

205.252

Identifier Type: -

Identifier Source: org_study_id