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)
Verified date | August 2008 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4 |
Est. completion date | November 2005 |
Est. primary completion date | November 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - FEV1 less than/equal to 70 % predicted, FEV1/FVC ratio less than/equal to 70%, and FRC greater than/equal to 120 % predicted - Moderate to severe chronic activity-related dyspnea (modified Baseline Dyspnea Index focal score less than/equal to 6) - Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospital admissions in the preceding four weeks - Males or females greater than 40 years of age; - A cigarette smoking history of at least 20 pack-years - Able to perform all study procedures and sign informed consent Exclusion Criteria: - History of asthma, atopy or nasal polyps - Recent history of cardiovascular disease (< 1 year) or other significant disease that could contribute to dyspnea or exercise limitation - Oxygen saturation less than 80% during exercise on room air |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Respiratory Investigation Unit | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Queen's University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | endurance time | 60 minutes post-inhalation | No | |
Primary | dyspnea | 60-minutes post-inhalation | No |
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