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Effect of Tiotropium (Spiriva) on Exercise Tolerance in COPD Patients

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tiotropium bromide
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 - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Sites / Locations

  • St. Elizabeth's Medical Center of Boston
  • Mayo Clinic
  • St. Thomas Health Services
  • Presbyterian Hospital of Dallas
  • Phase I Unit
  • Immunology Department
  • Department of Respiratory Medicine
  • The Queen Elizabeth Hospital
  • Department of Respiratory Medicine
  • Respiratory Research
  • University of Alberta
  • Respiratory Clinic
  • Boehringer Ingelheim Investigational Site
  • Cardio Repiratory
  • Kingston General Hospital
  • 1053 Carling Avenue
  • Department of Respiratory Medicine
  • University Health Network - Toronto General Hospital
  • Montreal Chest Institute - McGill University Health Centre
  • Pulmonary Function Lab
  • Hopital Laval
  • Boehringer Ingelheim Investigational Site
  • Pneumologisches Forschungsinstitut GmbH am Krankenhaus
  • Fraunhofer-Institut für Toxikologie und
  • Universitätsklinikum Schleswig-Holstein
  • Klinikum der Universität zu Köln
  • Neurologische Klinik der Otto-von-Guericke-Universität
  • Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

Endurance time during a constant work rate exercise test to symptom limitation

Secondary Outcome Measures

Constant work rate exercise test to symptom limitation
Breathing discomfort during constant work rate exercise test as measured by the modified Borg Scale
Dynamic lung hyperinflation during exercise as determined by IRVdyn (IC minus VT) and EELVdyn (TLC)
Evaluation of VE and VEcap during exercise (selected centers)
Evaluation of static lung hyperinflation as measured by RV/TLC and by TGV(FRC)/TLC
Evaluation of TAC (TAV = TLC(BOX)-VA(IG))
Evaluation of slow vital capacity (SVC)
Evaluation of maximal expiratory flow rates and volumes FEV1, FVC, FEF25-75%, FEF50%, FEF75%, SVC
Evaluation of TGV, Raw, SGaw and RV
Evaluation of SaO2, VO2, VCO2, Ti, Te, VE, VT, breathing frequency (f) during constant work rate exercise test
Physician's Global Assessment
Assessement of Pulse/heart rate and blood pressure in conjunction with spirometry and exercise
Changes in Physical examination and ECG
Occurrence of Adverse Events

Full Information

First Posted
January 9, 2006
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00274508
Brief Title
Effect of Tiotropium (Spiriva) on Exercise Tolerance in COPD Patients
Official Title
Effect of Tiotropium on Exercise Tolerance and Static and Dynamic Lung Volumes in COPD Patients (A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
To investigate whether tiotropium (Spiriva) improves exercise endurance in patients with COPD

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
261 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tiotropium bromide
Primary Outcome Measure Information:
Title
Endurance time during a constant work rate exercise test to symptom limitation
Time Frame
2 hours and 15 minutes after trial medication administration on Day 42
Secondary Outcome Measure Information:
Title
Constant work rate exercise test to symptom limitation
Time Frame
8 hours post-dose after 6 weeks of treatment
Title
Breathing discomfort during constant work rate exercise test as measured by the modified Borg Scale
Time Frame
6 weeks
Title
Dynamic lung hyperinflation during exercise as determined by IRVdyn (IC minus VT) and EELVdyn (TLC)
Time Frame
6 weeks
Title
Evaluation of VE and VEcap during exercise (selected centers)
Time Frame
6 weeks
Title
Evaluation of static lung hyperinflation as measured by RV/TLC and by TGV(FRC)/TLC
Time Frame
6 weeks
Title
Evaluation of TAC (TAV = TLC(BOX)-VA(IG))
Time Frame
6 weeks
Title
Evaluation of slow vital capacity (SVC)
Time Frame
6 weeks
Title
Evaluation of maximal expiratory flow rates and volumes FEV1, FVC, FEF25-75%, FEF50%, FEF75%, SVC
Time Frame
6 weeks
Title
Evaluation of TGV, Raw, SGaw and RV
Time Frame
6 weeks
Title
Evaluation of SaO2, VO2, VCO2, Ti, Te, VE, VT, breathing frequency (f) during constant work rate exercise test
Time Frame
6 weeks
Title
Physician's Global Assessment
Time Frame
6 weeks
Title
Assessement of Pulse/heart rate and blood pressure in conjunction with spirometry and exercise
Time Frame
6 weeks
Title
Changes in Physical examination and ECG
Time Frame
6 weeks
Title
Occurrence of Adverse Events
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
St. Elizabeth's Medical Center of Boston
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
St. Thomas Health Services
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Presbyterian Hospital of Dallas
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Phase I Unit
City
Randwick
State/Province
New South Wales
Country
Australia
Facility Name
Immunology Department
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Department of Respiratory Medicine
City
Daw Park
State/Province
South Australia
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville
State/Province
South Australia
Country
Australia
Facility Name
Department of Respiratory Medicine
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Respiratory Research
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Respiratory Clinic
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Cardio Repiratory
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
1053 Carling Avenue
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Department of Respiratory Medicine
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Montreal Chest Institute - McGill University Health Centre
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Pulmonary Function Lab
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hopital Laval
City
Ste-Foy
State/Province
Quebec
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Pneumologisches Forschungsinstitut GmbH am Krankenhaus
City
Hamburg
Country
Germany
Facility Name
Fraunhofer-Institut für Toxikologie und
City
Hannover
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
Country
Germany
Facility Name
Klinikum der Universität zu Köln
City
Köln
Country
Germany
Facility Name
Neurologische Klinik der Otto-von-Guericke-Universität
City
Magdeburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
München
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.223_U04-3016.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.223_literature.pdf
Description
Related Info

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Effect of Tiotropium (Spiriva) on Exercise Tolerance in COPD Patients

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