Status:
COMPLETED
Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with COPD. The hypoth...
Detailed Description
The study is a randomized trial with crossover of consecutively recruited patients with symptomatic COPD. Each patient will participate in seven visits over a 3-4 week period. At the first visit patie...
Eligibility Criteria
Inclusion
- male or female patient 50 years of age or older; diagnosis of COPD; current or ex-smoker with at least 10 pack-years of smoking; a patient-reported score for breathlessness during activities of daily living of \< 9 on the self-administered computerized baseline dyspnea index; a post-bronchodilator FEV1 \< 80% predicted; a post-bronchodilator FEV1/FVC ratio \< 70%; and clinically stable condition.
Exclusion
- any concomitant disease that interferes with study procedures or evaluation; inability to exercise on the treadmill or cycle ergometer; inability to withhold short-acting bronchodilators for 4 hours or long-acting bronchodilators for 12 hrs (salmeterol or formoterol) and for 24 hours (tiotropium) prior to testing
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00754546
Start Date
August 1 2008
End Date
May 1 2009
Last Update
May 29 2013
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001