Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Acute Effects of Inhaled Corticosteroids on Dynamic Airway Function During Rest and Exercise in Chronic Obstructive Pulmonary Disease (COPD)
Human and animal studies have shown that inhaled corticosteroids (ICS) decrease airway blood
flow . This effect is immediate (within 30 minutes), transient (lasting 90 minutes), and in
animal studies independent of gene expression. In COPD patients, decrease in bronchial blood
flow may also decrease mucosal edema, airway resistance and improve small airway function.
If such an effect exists, then we should be able to measure improvements in airway
conductance and reduce lung hyperinflation, which would have salutary effects on dyspnea and
exercise endurance.
To our knowledge, no study has examined the immediate effect of ICS on small airway function
in COPD. The purpose of this study is to examine the effects of nebulized Pulmicort on small
airway function (spirometry, plethysmographic lung volumes, airways resistance, closing
volume, partial flow-volume loop analysis) and exercise endurance in patients with moderate
to severe COPD.
HYPOTHESIS
1. Nebulized ICS will immediately improve airway function compared with placebo (nebulized
saline).
2. Enhanced lung emptying and reduced operating lung volumes during rest and exercise
following ICS therapy will translate acutely into clinically important reductions in
exertional dyspnea and improvements in exercise endurance.
This will be a single site, pilot, randomized, double-blinded, placebo-controlled,
cross-over study that will be conducted at this centre. Subjects will be required to
complete four (4) visits to the laboratory over a one-month period.
At Visit 1, subjects who meet all study inclusion and exclusion criteria, will have a full
set of pulmonary function tests (PFT) done and complete a symptom-limited incremental cycle
exercise test. At Visit 2, subjects will have a partial set of pulmonary function tests
(PFT) done and complete a symptom-limited constant load cycle exercise test. On the third
and fourth visit subjects will be randomized to treatment with either nebulized saline or
nebulized Pulmicort® in a double blinded, cross-over design, subsequent to which they will
have their PFT's and symptom limited constant load exercise testing done.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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