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 Randomised, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Comparison of 12-Week Treatment of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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

429

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

  • Germany
      • Berlin, Germany
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • MEDARS GmbH
      • Bonn, Germany
        • Boehringer Ingelheim Investigational Site
      • Frankfurt/Main, Germany
        • Boehringer Ingelheim Investigational Site
      • Gauting, Germany
        • Inamed Research GmbH & Co. KG
      • Großhansdorf, Germany
        • Pneumologisches Forschungsinstitut GmbH
      • Hamburg, Germany
        • Pneumologisches Forschungsinstitut GmbH am Krankenhaus
      • Hannover, Germany
        • Boehringer Ingelheim Investigational Site
      • Kiel, Germany
        • Universitätsklinikum Schleswig-Holstein
      • Leipzig, Germany
        • ClinPharm International GmbH & Co. KG
      • Magdeburg, Germany
        • Neurologische Klinik der Otto-von-Guericke-Universität
      • Mainz, Germany
        • Johannes-Gutenberg-Universität Mainz
      • Minden, Germany
        • Boehringer Ingelheim Investigational Site
      • Moers, Germany
        • Medizinische Klinik Iii
      • München, Germany
        • Boehringer Ingelheim Investigational Site
      • Schmallenberg, Germany
        • Abt. Lungen- und Bronchialheilkunde
      • Steinfurt, Germany
        • Boehringer Ingelheim Investigational Site
  • Italy
      • Ascoli Piceno, Italy
        • Ospedale Generale Provinciale Mazzoni
      • Catania, Italy
        • Dip. di Medicina Interna e Medicina Specialistica
      • Ferrara, Italy
        • U. O. di Fisiopatologia Respiratoria
      • Genova, Italy
        • Ospedale S. Martino
      • Milano, Italy
        • U. O. di Pneumologia e Servizio di Fisiopatologia Resp.
      • Pavia, Italy
        • IRCCS Policlinico San Matteo
      • Roma, Italy
        • U. O. C di Pneumologia
      • San Sisto (pg), Italy
        • Ospedale Silvestrini
      • Trieste, Italy
        • U. O. di Pneumologia
  • South Africa
      • Bloemfontein, South Africa
        • Hydromed Hospital
      • Cape Town, South Africa
        • UCT Lung Institute
      • Pretoria, South Africa
        • 1 Military Hospital
      • Tygerberg, South Africa
        • Tygerberg hospital
  • Switzerland
      • Basel, Switzerland
        • Universitätskliniken Basel
      • Bellinzona, Switzerland
        • Ospedale San Giovanni
      • Davos, Switzerland
        • Boehringer Ingelheim Investigational Site
      • Laufen, Switzerland
        • Boehringer Ingelheim Investigational Site
      • Locarno, Switzerland
        • Boehringer Ingelheim Investigational Site
      • Lugano, Switzerland
        • Ospedale Regionale
      • Münchenstein, Switzerland
        • Boehringer Ingelheim Investigational Site
      • St. Gallen, Switzerland
        • Kantonsspital St. Gallen

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
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 (AUC)0-6h 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
Time Frame: during 12 weeks
during 12 weeks
Onset and duration of 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 (peak expiratory flow rate)
Time Frame: up to 12 weeks
up to 12 weeks
Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol)
Time Frame: up to 12 weeks
up to 12 weeks
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Time Frame: up to 15 weeks
up to 15 weeks
Physician's Global Evaluation
Time Frame: up to 15 weeks
up to 15 weeks
Number of patients with at least one exacerbation of COPD
Time Frame: up to 15 weeks
up to 15 weeks
Time to first exacerbation
Time Frame: up to 15 weeks
up to 15 weeks
Number of exacerbations and exacerbation days
Time Frame: up to 15 weeks
up to 15 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 17, 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

  • 205.251

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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