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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
  • Boehringer Ingelheim Investigational Site
  • University of California - Los Angeles
  • Boehringer Ingelheim Investigational Site
  • Rocky Mountain Center for Clinical Research
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • St. Boniface General Hospital
  • Boehringer Ingelheim Investigational Site
  • St. Joseph's Hospital Cardiac Research
  • Boehringer Ingelheim Investigational Site
  • Department of Respiratory Medicine
  • Toronto General Hospital
  • SMBD--Jewish General Hospital
  • Centre de Recherche Clinique -CUSE
  • Hopital Laval
  • c/o Hemodynamics Offices

Outcomes

Primary Outcome Measures

Trough FEV1 response after 12 weeks of treatment.

Secondary Outcome Measures

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

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
NCT00240435
Brief Title
12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD
Official Title
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
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
491 (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 after 12 weeks of treatment.
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 and peak response
Time Frame
after 0, 1, 4, 8 and 12 weeks
Title
Individual FEV1 and FVC measurements at each time point
Time Frame
during study course of 12 weeks
Title
Therapeutic response and percentage of responders
Time Frame
after 0 and 12 weeks
Title
Weekly mean pre-dose morning and evening PEFR
Time Frame
during study course of 12 weeks
Title
Number of occasions of rescue therapy used per day (PRN salbutamol)
Time Frame
during study course of 12 weeks
Title
COPD symptom scores
Time Frame
during 15 weeks
Title
Physician's Global Evaluation
Time Frame
during 15 weeks
Title
Number of patients with at least one exacerbation of COPD
Time Frame
15 weeks
Title
time to first exacerbation
Time Frame
15 weeks
Title
number of exacerbations
Time Frame
15 weeks
Title
number of exacerbation days
Time Frame
15 weeks
Title
Patient satisfaction and preference
Time Frame
12 weeks
Title
All adverse events
Time Frame
during 15 weeks, follow-up period included
Title
Pulse rate and blood pressure for the first three hours following dosing
Time Frame
after 0, 1, 4, 8 and 12 weeks
Title
Routine blood chemistry, haematology and urinalysis
Time Frame
after 12 weeks
Title
12-lead ECG
Time Frame
after 12 weeks
Title
Physical examination
Time Frame
after 12 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
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Downey
State/Province
California
Country
United States
Facility Name
University of California - Los Angeles
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Palo Alto
State/Province
California
Country
United States
Facility Name
Rocky Mountain Center for Clinical Research
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Bay Pines
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Wheaton
State/Province
Maryland
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Elizabeth City
State/Province
North Carolina
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Courtice
State/Province
Ontario
Country
Canada
Facility Name
St. Joseph's Hospital Cardiac Research
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Department of Respiratory Medicine
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
SMBD--Jewish General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre de Recherche Clinique -CUSE
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Hopital Laval
City
Ste-Foy
State/Province
Quebec
Country
Canada
Facility Name
c/o Hemodynamics Offices
City
Saskatoon
State/Province
Saskatchewan
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.252_U04-3343.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.252_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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