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
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 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 Physician's Global Assessment 6 weeks
Trial Locations
- Locations (24)
St. Elizabeth's Medical Center of Boston
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
St. Thomas Health Services
🇺🇸Nashville, Tennessee, United States
Presbyterian Hospital of Dallas
🇺🇸Dallas, Texas, United States
Phase I Unit
🇦🇺Randwick, New South Wales, Australia
Immunology Department
🇦🇺Westmead, New South Wales, Australia
Department of Respiratory Medicine
🇨🇦Toronto, Ontario, Canada
The Queen Elizabeth Hospital
🇦🇺Woodville, South Australia, Australia
Respiratory Research
🇨🇦Calgary, Alberta, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Scroll for more (14 remaining)St. Elizabeth's Medical Center of Boston🇺🇸Boston, Massachusetts, United States