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

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00274508
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-10-10
• Primary Completion: 2003-01-07
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endurance time during a constant work rate exercise test to symptom limitation	2 hours and 15 minutes after trial medication administration on Day 42

Secondary Outcome Measures

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

Trial Locations

Locations (24)

St. Thomas Health Services; 🇺🇸 Nashville, Tennessee, United States

Presbyterian Hospital of Dallas; 🇺🇸 Dallas, Texas, United States

Department of Respiratory Medicine; 🇨🇦 Toronto, Ontario, Canada

University Health Network - Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Cardio Repiratory; 🇨🇦 Hamilton, Ontario, Canada

Boehringer Ingelheim Investigational Site; 🇩🇪 München, Germany

Fraunhofer-Institut für Toxikologie und; 🇩🇪 Hannover, Germany

Neurologische Klinik der Otto-von-Guericke-Universität; 🇩🇪 Magdeburg, Germany

Respiratory Clinic; 🇨🇦 Vancouver, British Columbia, Canada

Montreal Chest Institute - McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Hopital Laval; 🇨🇦 Ste-Foy, Quebec, Canada

Immunology Department; 🇦🇺 Westmead, New South Wales, Australia

1053 Carling Avenue; 🇨🇦 Ottawa, Ontario, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Pulmonary Function Lab; 🇨🇦 Montreal, Quebec, Canada

Klinikum der Universität zu Köln; 🇩🇪 Köln, Germany

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Germany

St. Elizabeth's Medical Center of Boston; 🇺🇸 Boston, Massachusetts, United States

The Queen Elizabeth Hospital; 🇦🇺 Woodville, South Australia, Australia

Phase I Unit; 🇦🇺 Randwick, New South Wales, Australia

Respiratory Research; 🇨🇦 Calgary, Alberta, Canada

Pneumologisches Forschungsinstitut GmbH am Krankenhaus; 🇩🇪 Hamburg, Germany