Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Bronchodilator Effect on O2 Deficit and V'O2 Kinetics During Moderate Intensity Exercise in Normoxemic COPD.
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.
The inability to engage in the usual activities of daily living is one of the most
distressing experiences of people afflicted with Chronic Obstructive Pulmonary Disease
(COPD). Exercise intolerance progresses relentlessly as the disease advances and can lead to
virtual immobility and social isolation. Our understanding of the complex interface between
physiological impairment and disability in COPD has increased considerably in recent years.
It has become clear that in COPD, exercise intolerance ultimately reflects integrated
abnormalities of the ventilatory, cardiovascular, peripheral muscle and neurosensory
systems. Ventilatory constraint is the dominant contributor to exercise limitation in more
advanced disease. Recently, important studies have been conducted on the role of peripheral
muscle dysfunction in exercise limitation in COPD.
The present study will test the hypothesis that the administration of bronchodilators (i.e.,
inhaled β2-agonist and inhaled anticholinergics in combination) in normoxemic COPD patients
during moderate-intensity constant-load exercise may result in an enhancement of oxidative
metabolism, reflected by reductions of O2 def and phase 2 tV'O2.
Fifteen normoxemic patients with stable COPD (FEV1 less than 60 % predicted) and severe
chronic breathlessness (Baseline Dyspnea Index less than 6) will complete the study.
Each patient will perform three visits. At the first visit, patients will be familiarized
with the various questionnaires and scales for rating the intensity and quality of symptoms
and they will carry out pulmonary function testing and a symptom-limited incremental cycle
exercise test in order to determine the anaerobic threshold (AT), the peak work-rate and the
peak oxygen uptake. Each patient will subsequently complete two visits in which they will
receive either nebulized bronchodilator (BD) (Combivent®, ipratropium 0.5 mg + salbutamol
2.5 mg) or placebo (PL), in random order. At 90-100 minutes post-dose, patients will perform
pulmonary function tests, then they will perform a constant-load exercise test at 80% of AT
V'O2. During constant-load exercise tests (2nd and 3rd visit), small samples of blood from
the earlobe of each subject will be collected in order to determine the level of lactate and
breathing gases (oxygen and carbon dioxide) in the blood.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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