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Anti-Inflammatory Effects of Salmeterol/Fluticasone Propionate in Chronic Obstructive Lung Disease.

Author(s): Barnes NC, Qiu YS, Pavord ID, Parker D, Davis PA, Zhu J, Johnson M, Thomson NC, Jeffery PK

Affiliation(s): Department of Respiratory Medicine, London Chest Hospital, London, United Kingdom.

Publication date & source: 2006-01-19, Am J Respir Crit Care Med., [Epub ahead of print]

Rationale: No currently available treatment is reported to reduce the exaggerated airway wall inflammation of chronic obstructive pulmonary disease. Objectives: We tested the hypothesis that inhaled combined long-acting beta2-agonist (salmeterol) and corticosteroid (fluticasone propionate) will reduce inflammation Methods: Bronchial biopsies and induced sputum were taken from 140 current and former smokers (mean age 64 years) with moderate to severe disease, randomized in a 13-week double-blind study to placebo (n=73) or salmeterol/fluticasone propionate 50/500microg (n=67) twice daily. Biopsies were repeated at 12 and sputa at 8 and 13 weeks. Following adjustment for multiplicity, comparisons between active and placebo were made for median change from baseline in the numbers of biopsy CD8+ and CD68+ cells/mm(2) and sputum neutrophils. Measurements and Main Results: Combination therapy was associated with a reduction in biopsy CD8+ cells of -118 cells/mm(2) (95%CI -209,-42; p=0.02), a reduction of 36% over placebo (p=0.001). CD68+ cells were unaffected by combination treatment. Sputum differential (but not total) neutrophils reduced progressively and, at week 13, significantly with combination treatment (median treatment difference 8.5%; 95%CI 1.75%,15.25%; p=0.04). The combination also significantly reduced biopsy CD45+, CD4+ and cells expressing genes for tumor necrosis factor-alpha and interferon-gamma and sputum total eosinophils (all p</=0.03). These anti-inflammatory effects were accompanied by 173mL (95%CI 104,242; p<0.001) improvement in pre-bronchodilator forced expiratory volume in one second. Conclusions: Salmeterol/fluticasone propionate has a broad spectrum of anti-inflammatory effects in both current and former smokers with chronic obstructive pulmonary disease, which may contribute to clinical efficacy.

Page last updated: 2006-01-31

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