Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Bronchodilator Effect on O2 Deficit and V'O2 Kinetics During Moderate Intensity Exercise in Normoxemic COPD.
Verified date | April 2011 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Hypothesis: The reduction of dynamic hyperinflation and its negative effects on the
respiratory system following a bronchodilator could lead to an improvement of cardiac
function in terms of increased cardiac output. This may enhance oxygen delivery to the
exercising muscles in COPD patients. Bronchodilator administration may also have an indirect
effect on V'O2 kinetics via its action on cardiovascular and pulmonary variables.
Objectives:
1. To evaluate the effects of a bronchodilators on V'E , V'CO2 , and V'O2 kinetics in COPD
during constant work-rate cycle exercise, and to evaluate whether bronchodilators will
accelerate, indirectly, phase 2 kinetics (usually slower in COPD patients than normal
subjects) and shorten t for V'E, V'CO2 , and V'O2 and shorten half-times for HR and O2
pulse, thus showing an improvement of oxygen transport to the peripheral active
muscles.
2. To determine the impact of a bronchodilator-induced reduction in dynamic
hyperinflation, and its effects on cardiovascular and pulmonary function, on exercise
limitation in COPD.
Status | Completed |
Enrollment | 12 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 40-80 years - stable COPD - FEV1 < 60 % predicted - severe chronic breathlessness (Baseline Dyspnea Index < 6) Exclusion Criteria: - SpO2 at rest < 90% or a a sustained decrease of > 4% in arterial O2 saturation during the ergometer test, as determined by pulse oximetry - a body mass index (BMI) < 19 or > 30 - chronic oral steroid therapy - other medical conditions which could cause or contribute to breathlessness, i.e., heart disease or other respiratory diseases - other problem which could interfere with carrying out of exercise testing, i.e., neuromuscular diseases, orthopedic diseases, etc. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Respiratory Investigation Unit (Queen's University) | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Queen's University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | effects of bronchodilators on V'E , V'CO2 , and V'O2 kinetics in COPD during constant work-rate cycle exercise. | 2 hours post-inhalation of study drug | No | |
Primary | evaluate whether bronchodilators will accelerate, indirectly, phase 2 kinetics in COPD | 2 hours post-inhalation of study drug | No | |
Primary | evaluate whether bronchodilators will shorten t for V'E, V'CO2 , and V'O2 | 2 hours post-inhalation of study drug | No | |
Primary | evaluate whether bronchodilators will shorten half-times for HR and O2 pulse | 2 hours post-inhalation of study drug | No |
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