Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Pilot Study of the Mechanism of Synergism Between Fluticasone (FP) and Salmeterol in Preventing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
The purpose of this study is to evaluate the blood and airway of subjects with mild to moderate COPD while undergoing standard treatment.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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