|Title||The effects of fluticasone with or without salmeterol on systemic biomarkers of inflammation in chronic obstructive pulmonary disease.|
|Publication Type||Journal Article|
|Year of Publication||2008|
|Authors||Sin, DD, Man, SFPaul, Marciniuk, DD, Ford, G, FitzGerald, M, Wong, E, York, E, Mainra, RR, Ramesh, W, Melenka, LS, Wilde, E, Cowie, RL, Williams, D, Gan, WQ, Rousseau, R|
|Corporate Authors||ABC (Advair, Biomarkers in COPD) Investigators|
|Journal||Am J Respir Crit Care Med|
|Date Published||2008 Jun 1|
|Keywords||Administration, Inhalation, Adrenergic beta-Agonists, Aged, Albuterol, Androstadienes, Anti-Inflammatory Agents, Biological Markers, C-Reactive Protein, Canada, Double-Blind Method, Drug Combinations, Female, Humans, Interleukin-6, Male, Middle Aged, Pulmonary Disease, Chronic Obstructive, Pulmonary Surfactant-Associated Protein D, Respiratory Function Tests, Treatment Outcome|
RATIONALE: Small studies have suggested that inhaled corticosteroids can suppress systemic inflammation in chronic obstructive pulmonary disease (COPD).
OBJECTIVES: To determine the effect of inhaled corticosteroids with or without long-acting beta(2)-adrenergic agonist on systemic biomarkers of inflammation.
METHODS: We conducted a double-blind randomized placebo-controlled trial across 11 centers (n = 289 patients with FEV(1) of 47.8 +/- 16.2% of predicted) to compare the effects of inhaled fluticasone alone or in combination with salmeterol against placebo on circulating biomarkers of systemic inflammation over 4 weeks. The primary endpoint was C-reactive protein (CRP) level. Secondary molecules of interest were IL-6 and surfactant protein D (SP-D).
MEASUREMENTS AND MAIN RESULTS: Neither fluticasone nor the combination of fluticasone/salmeterol had a significant effect on CRP or IL-6 levels. There was, however, a significant reduction in SP-D levels with fluticasone and fluticasone/salmeterol compared with placebo (P = 0.002). Health status also improved significantly in both the fluticasone and fluticasone/salmeterol groups compared with placebo, driven mostly by improvements in the symptom scores. Changes in the circulating SP-D levels were related to changes in health status scores. FEV(1) improved significantly only in the fluticasone/salmeterol group compared with placebo.
CONCLUSIONS: ICS in conjunction with long-acting beta(2)-adrenergic agonist do not reduce CRP or IL-6 levels in serum of patients with COPD over 4 weeks. They do, however, significantly reduce serum SP-D levels. These data suggest that these drugs reduce lung-specific but not generalized biomarkers of systemic inflammation in COPD.
|Alternate Journal||Am. J. Respir. Crit. Care Med.|