To investigate whether tiotropium (Spiriva) improves exercise endurance in patients with COPD
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
261
St. Elizabeth's Medical Center of Boston
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
Constant work rate exercise test to symptom limitation
Time frame: 8 hours post-dose after 6 weeks of treatment
Breathing discomfort during constant work rate exercise test as measured by the modified Borg Scale
Time frame: 6 weeks
Dynamic lung hyperinflation during exercise as determined by IRVdyn (IC minus VT) and EELVdyn (TLC)
Time frame: 6 weeks
Evaluation of VE and VEcap during exercise (selected centers)
Time frame: 6 weeks
Evaluation of static lung hyperinflation as measured by RV/TLC and by TGV(FRC)/TLC
Time frame: 6 weeks
Evaluation of TAC (TAV = TLC(BOX)-VA(IG))
Time frame: 6 weeks
Evaluation of slow vital capacity (SVC)
Time frame: 6 weeks
Evaluation of maximal expiratory flow rates and volumes FEV1, FVC, FEF25-75%, FEF50%, FEF75%, SVC
Time frame: 6 weeks
Evaluation of TGV, Raw, SGaw and RV
Time frame: 6 weeks
Evaluation of SaO2, VO2, VCO2, Ti, Te, VE, VT, breathing frequency (f) during constant work rate exercise test
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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
Daw Park, South Australia, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Department of Respiratory Medicine
Heidelberg, Victoria, Australia
Respiratory Research
Calgary, Alberta, Canada
...and 18 more locations
Time frame: 6 weeks
Physician's Global Assessment
Time frame: 6 weeks
Assessement of Pulse/heart rate and blood pressure in conjunction with spirometry and exercise
Time frame: 6 weeks
Changes in Physical examination and ECG
Time frame: 6 weeks
Occurrence of Adverse Events
Time frame: 6 weeks