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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boehringer Ingelheim Investigational Site
  • MEDARS GmbH
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Inamed Research GmbH & Co. KG
  • Pneumologisches Forschungsinstitut GmbH
  • Pneumologisches Forschungsinstitut GmbH am Krankenhaus
  • Boehringer Ingelheim Investigational Site
  • Universitätsklinikum Schleswig-Holstein
  • ClinPharm International GmbH & Co. KG
  • Neurologische Klinik der Otto-von-Guericke-Universität
  • Johannes-Gutenberg-Universität Mainz
  • Boehringer Ingelheim Investigational Site
  • Medizinische Klinik III
  • Boehringer Ingelheim Investigational Site
  • Abt. Lungen- und Bronchialheilkunde
  • Boehringer Ingelheim Investigational Site
  • Ospedale Generale Provinciale Mazzoni
  • Dip. di Medicina Interna e Medicina Specialistica
  • U. O. di Fisiopatologia Respiratoria
  • Ospedale S. Martino
  • U. O. di Pneumologia e Servizio di Fisiopatologia Resp.
  • IRCCS Policlinico San Matteo
  • U. O. C di Pneumologia
  • Ospedale Silvestrini
  • U. O. di Pneumologia
  • Hydromed Hospital
  • UCT Lung Institute
  • 1 Military Hospital
  • Tygerberg Hospital
  • Universitätskliniken Basel
  • Ospedale San Giovanni
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Ospedale Regionale
  • Boehringer Ingelheim Investigational Site
  • Kantonsspital St. Gallen

Outcomes

Primary Outcome Measures

Trough FEV1 response

Secondary Outcome Measures

Trough FEV1 response
Trough FVC response
FEV1 and FVC area under the curve (AUC)0-6h and peak response
Individual FEV1 and FVC measurements
Onset and duration of therapeutic response and percentage of responders
Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate)
Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol)
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Physician's Global Evaluation
Number of patients with at least one exacerbation of COPD
Time to first exacerbation
Number of exacerbations and exacerbation days

Full Information

First Posted
October 14, 2005
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00239473
Brief Title
12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
429 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
Intervention Type
Device
Intervention Name(s)
10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
Primary Outcome Measure Information:
Title
Trough FEV1 response
Time Frame
after 12 weeks
Secondary Outcome Measure Information:
Title
Trough FEV1 response
Time Frame
after 1, 4 and 8 weeks
Title
Trough FVC response
Time Frame
after 1, 4, 8 and 12 weeks
Title
FEV1 and FVC area under the curve (AUC)0-6h and peak response
Time Frame
after 0, 1, 4, 8 and 12 weeks
Title
Individual FEV1 and FVC measurements
Time Frame
during 12 weeks
Title
Onset and duration of therapeutic response and percentage of responders
Time Frame
after 0 and 12 weeks
Title
Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate)
Time Frame
up to 12 weeks
Title
Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol)
Time Frame
up to 12 weeks
Title
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Time Frame
up to 15 weeks
Title
Physician's Global Evaluation
Time Frame
up to 15 weeks
Title
Number of patients with at least one exacerbation of COPD
Time Frame
up to 15 weeks
Title
Time to first exacerbation
Time Frame
up to 15 weeks
Title
Number of exacerbations and exacerbation days
Time Frame
up to 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Outpatients of either sex, aged >/= 40 years with a diagnosis of COPD (FEV1 </= 60% predicted [ECCS criteria] and FEV1/FVC </= 70%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
MEDARS GmbH
City
Berlin
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bonn
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Frankfurt/Main
Country
Germany
Facility Name
Inamed Research GmbH & Co. KG
City
Gauting
Country
Germany
Facility Name
Pneumologisches Forschungsinstitut GmbH
City
Großhansdorf
Country
Germany
Facility Name
Pneumologisches Forschungsinstitut GmbH am Krankenhaus
City
Hamburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
Country
Germany
Facility Name
ClinPharm International GmbH & Co. KG
City
Leipzig
Country
Germany
Facility Name
Neurologische Klinik der Otto-von-Guericke-Universität
City
Magdeburg
Country
Germany
Facility Name
Johannes-Gutenberg-Universität Mainz
City
Mainz
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Minden
Country
Germany
Facility Name
Medizinische Klinik III
City
Moers
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
Abt. Lungen- und Bronchialheilkunde
City
Schmallenberg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Steinfurt
Country
Germany
Facility Name
Ospedale Generale Provinciale Mazzoni
City
Ascoli Piceno
Country
Italy
Facility Name
Dip. di Medicina Interna e Medicina Specialistica
City
Catania
Country
Italy
Facility Name
U. O. di Fisiopatologia Respiratoria
City
Ferrara
Country
Italy
Facility Name
Ospedale S. Martino
City
Genova
Country
Italy
Facility Name
U. O. di Pneumologia e Servizio di Fisiopatologia Resp.
City
Milano
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
U. O. C di Pneumologia
City
Roma
Country
Italy
Facility Name
Ospedale Silvestrini
City
San Sisto (pg)
Country
Italy
Facility Name
U. O. di Pneumologia
City
Trieste
Country
Italy
Facility Name
Hydromed Hospital
City
Bloemfontein
Country
South Africa
Facility Name
UCT Lung Institute
City
Cape Town
Country
South Africa
Facility Name
1 Military Hospital
City
Pretoria
Country
South Africa
Facility Name
Tygerberg Hospital
City
Tygerberg
Country
South Africa
Facility Name
Universitätskliniken Basel
City
Basel
Country
Switzerland
Facility Name
Ospedale San Giovanni
City
Bellinzona
Country
Switzerland
Facility Name
Boehringer Ingelheim Investigational Site
City
Davos
Country
Switzerland
Facility Name
Boehringer Ingelheim Investigational Site
City
Laufen
Country
Switzerland
Facility Name
Boehringer Ingelheim Investigational Site
City
Locarno
Country
Switzerland
Facility Name
Ospedale Regionale
City
Lugano
Country
Switzerland
Facility Name
Boehringer Ingelheim Investigational Site
City
Münchenstein
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.251_U04-3400.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.251_literature.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/Pooled%20analysis/PA_205.372_251_252_254_255_U10-3255-01.pdf
Description
Related Info

Learn more about this trial

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

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