Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202189
Status:
COMPLETED
Last Update Posted:
2008-08-13
First Post:
2005-09-09
Brief Title:
Effects of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease COPD
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
Acute Effects of Inhaled Corticosteroids on Dynamic Airway Function During Rest and Exercise in Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 PFTs and symptom limited constant load exercise testing done
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 PFTs and symptom limited constant load exercise testing done
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None