Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT00116402
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
2005-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study of the Mechanism of Synergism Between FP and Salmeterol in Preventing COPD Exacerbations
Sponsor:
University of Chicago
Organization:
Study Overview
Official Title:
A Pilot Study of the Mechanism of Synergism Between Fluticasone (FP) and Salmeterol in Preventing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Status:
COMPLETED
Status Verified Date:
2014-08
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:
The purpose of this study is to evaluate the blood and airway of subjects with mild to moderate COPD while undergoing standard treatment.
Detailed Description:
Our objective is to examine the mechanism of the additive/synergistic properties of b2-adrenoceptor stimulation and corticosteroid receptor activation in:
* Preventing neutrophil adhesion to specific endothelial ligands, e.g. ICAM-1 and
* Undergoing activation as a consequence of this adhesion.
We hypothesize that combination therapy with salmeterol + fluticasone (FP) will:
* Augment the inhibition of adhesion of neutrophils obtained from the peripheral blood of study subjects in vitro, by blocking gIV-PLA2 translocation to the nuclear membrane as for eosinophils;
* Augment the inhibition of transendothelial migration of neutrophils into airways of subjects with chronic obstructive pulmonary disease;
* Augment the numbers and concentrations of pro-inflammatory products in the bronchoalveolar lavage fluid; and
* Decrease the number of neutrophils in the bronchial tissue of endobronchial biopsies of treated patients.
* Preventing neutrophil adhesion to specific endothelial ligands, e.g. ICAM-1 and
* Undergoing activation as a consequence of this adhesion.
We hypothesize that combination therapy with salmeterol + fluticasone (FP) will:
* Augment the inhibition of adhesion of neutrophils obtained from the peripheral blood of study subjects in vitro, by blocking gIV-PLA2 translocation to the nuclear membrane as for eosinophils;
* Augment the inhibition of transendothelial migration of neutrophils into airways of subjects with chronic obstructive pulmonary disease;
* Augment the numbers and concentrations of pro-inflammatory products in the bronchoalveolar lavage fluid; and
* Decrease the number of neutrophils in the bronchial tissue of endobronchial biopsies of treated patients.
Study Oversight
Has Oversight DMC:
True
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?: