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

October 31, 2013 updated by: Boehringer Ingelheim

A Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison of 12-week Treatment of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) i

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

491

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • St. Boniface General Hospital
    • Ontario
      • Courtice, Ontario, Canada
        • Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada
        • St. Joseph's Hospital Cardiac Research
      • Toronto, Ontario, Canada
        • Toronto General Hospital
      • Toronto, Ontario, Canada
        • Department of respiratory medicine
      • Toronto, Ontario, Canada
        • Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • SMBD--Jewish General Hospital
      • Sherbrooke, Quebec, Canada
        • Centre de Recherche Clinique -CUSE
      • Ste-Foy, Quebec, Canada
        • Hôpital Laval
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • c/o Hemodynamics Offices
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Boehringer Ingelheim Investigational Site
    • California
      • Downey, California, United States
        • Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • University of California - Los Angeles
      • Palo Alto, California, United States
        • Boehringer Ingelheim Investigational Site
    • Colorado
      • Wheat Ridge, Colorado, United States
        • Rocky Mountain Center for Clinical Research
    • Florida
      • Bay Pines, Florida, United States
        • Boehringer Ingelheim Investigational Site
      • Clearwater, Florida, United States
        • Boehringer Ingelheim Investigational Site
      • Pembroke Pines, Florida, United States
        • Boehringer Ingelheim Investigational Site
    • Maryland
      • Wheaton, Maryland, United States
        • Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, United States
        • Boehringer Ingelheim Investigational Site
    • New York
      • New Hyde Park, New York, United States
        • Boehringer Ingelheim Investigational Site
    • North Carolina
      • Elizabeth City, North Carolina, United States
        • Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • Boehringer Ingelheim Investigational Site

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

No

Genders Eligible for Study

All

Description

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

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
Trough FEV1 response after 12 weeks of treatment.
Time Frame: after 12 weeks
after 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Trough FEV1 response
Time Frame: after 1, 4 and 8 weeks
after 1, 4 and 8 weeks
Trough FVC response
Time Frame: after 1, 4, 8 and 12 weeks
after 1, 4, 8 and 12 weeks
FEV1 and FVC area under the curve and peak response
Time Frame: after 0, 1, 4, 8 and 12 weeks
after 0, 1, 4, 8 and 12 weeks
Individual FEV1 and FVC measurements at each time point
Time Frame: during study course of 12 weeks
during study course of 12 weeks
Therapeutic response and percentage of responders
Time Frame: after 0 and 12 weeks
after 0 and 12 weeks
Weekly mean pre-dose morning and evening PEFR
Time Frame: during study course of 12 weeks
during study course of 12 weeks
Number of occasions of rescue therapy used per day (PRN salbutamol)
Time Frame: during study course of 12 weeks
during study course of 12 weeks
COPD symptom scores
Time Frame: during 15 weeks
during 15 weeks
Physician's Global Evaluation
Time Frame: during 15 weeks
during 15 weeks
Number of patients with at least one exacerbation of COPD
Time Frame: 15 weeks
15 weeks
time to first exacerbation
Time Frame: 15 weeks
15 weeks
number of exacerbations
Time Frame: 15 weeks
15 weeks
number of exacerbation days
Time Frame: 15 weeks
15 weeks
Patient satisfaction and preference
Time Frame: 12 weeks
12 weeks
All adverse events
Time Frame: during 15 weeks, follow-up period included
during 15 weeks, follow-up period included
Pulse rate and blood pressure for the first three hours following dosing
Time Frame: after 0, 1, 4, 8 and 12 weeks
after 0, 1, 4, 8 and 12 weeks
Routine blood chemistry, haematology and urinalysis
Time Frame: after 12 weeks
after 12 weeks
12-lead ECG
Time Frame: after 12 weeks
after 12 weeks
Physical examination
Time Frame: after 12 weeks
after 12 weeks

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

November 1, 2002

Primary Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

October 14, 2005

First Submitted That Met QC Criteria

October 14, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.252

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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