Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175565
Status:
COMPLETED
Last Update Posted:
2010-07-28
First Post:
2005-09-11
Brief Title:
Inhaled Steroid Reduces Systemic Inflammation in COPD
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Effects of Fluticasone On Systemic Markers of Inflammation in Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2010-07
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:
Systemic inflammation is present in chronic obstructive pulmonary disease COPD which has been linked to cardiovascular morbidity and mortality We determined the effects of oral and inhaled corticosteroids on serum markers of inflammation in patients with stable COPD
Detailed Description:
We recruited patients aged 45 to 80 years who had stable symptoms of COPD in the previous 3 months before study entry All patients had a forced expiratory volume in one second FEV1 after bronchodilation with 400 mcg salbutamol that was 25 to 90 of predicted a change of less than 20 of predicted FEV1 30 minutes following bronchodilation and a FEV1forced vital capacity FVC of less than 75 Patients also had a history of at least 10 pack-years of smoking or prolonged exposure 10 years to noxious gases eg diesel fumes
At the first visit patients who were taking inhaled corticosteroids were asked to immediately discontinue the use of these medications They were allowed to take other anti-COPD medications None of the patients took theophyllines at the time of study entry and no new medications were commenced between the first and second visits The patients returned 4 weeks later for a second visit at which point they were randomized into one of the three arms of the trial placebo capsules and a placebo puffer fluticasone 500 mcg twice daily and placebo capsules or prednisone 30 mg once daily and a placebo puffer The trial period lasted 2 weeks Patients were then assigned to fluticasone 500 mcg twice daily for 8 weeks in an un-blinded fashion followed by an additional 8 weeks of fluticasone at 1000 mcg twice daily At each visit we measure the participants serum C-reactive protein CRP level using nephelometry in accordance with recommendations from Center for Disease Control and the American Heart Association We also measured serum concentrations of interleukin-6 IL-6 and monocyte chemoattractant protein-1 MCP-1 IL-6 was measured because it is a powerful signaling cytokine for CRP expression by the liver and is a known independent risk factor for cardiovascular events2223 MCP-1 was measured because it may play a central role in the pathogenesis of COPD24 and by itself is a known risk factor for atherosclerosis myocardial infarction and cardiac deaths All samples were analyzed in duplicate
For analytic purposes continuous variables that were not normally distributed including CRP values were log-transformed to achieve normality We used a paired t-test to compare the log-transformed CRP values between visit 2 ie at the time of randomization and visit 3 at the end of the randomized trial phase within each treatment group Similarly using visit 2 as the referent CRP value we used paired t-tests to compare log-transformed CRP values across the visits To assess whether there was a gradient in the log-transformed CRP values between placebo fluticasone and prednisone groups we also used a Mantel-Haenszel test for trend We reasoned a priori that oral prednisone a more potent systemic corticosteroid than inhaled fluticasone would have the largest effect on CRP followed by fluticasone Linear regression was used to examine the association between changes in interleukin-6 and log-transformed CRP values between visit 1 and 2 and between visit 2 and 3 Continuous variables are expressed as meanSD unless otherwise specified
At the first visit patients who were taking inhaled corticosteroids were asked to immediately discontinue the use of these medications They were allowed to take other anti-COPD medications None of the patients took theophyllines at the time of study entry and no new medications were commenced between the first and second visits The patients returned 4 weeks later for a second visit at which point they were randomized into one of the three arms of the trial placebo capsules and a placebo puffer fluticasone 500 mcg twice daily and placebo capsules or prednisone 30 mg once daily and a placebo puffer The trial period lasted 2 weeks Patients were then assigned to fluticasone 500 mcg twice daily for 8 weeks in an un-blinded fashion followed by an additional 8 weeks of fluticasone at 1000 mcg twice daily At each visit we measure the participants serum C-reactive protein CRP level using nephelometry in accordance with recommendations from Center for Disease Control and the American Heart Association We also measured serum concentrations of interleukin-6 IL-6 and monocyte chemoattractant protein-1 MCP-1 IL-6 was measured because it is a powerful signaling cytokine for CRP expression by the liver and is a known independent risk factor for cardiovascular events2223 MCP-1 was measured because it may play a central role in the pathogenesis of COPD24 and by itself is a known risk factor for atherosclerosis myocardial infarction and cardiac deaths All samples were analyzed in duplicate
For analytic purposes continuous variables that were not normally distributed including CRP values were log-transformed to achieve normality We used a paired t-test to compare the log-transformed CRP values between visit 2 ie at the time of randomization and visit 3 at the end of the randomized trial phase within each treatment group Similarly using visit 2 as the referent CRP value we used paired t-tests to compare log-transformed CRP values across the visits To assess whether there was a gradient in the log-transformed CRP values between placebo fluticasone and prednisone groups we also used a Mantel-Haenszel test for trend We reasoned a priori that oral prednisone a more potent systemic corticosteroid than inhaled fluticasone would have the largest effect on CRP followed by fluticasone Linear regression was used to examine the association between changes in interleukin-6 and log-transformed CRP values between visit 1 and 2 and between visit 2 and 3 Continuous variables are expressed as meanSD unless otherwise specified
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