Published ahead of print on February 28, 2008, doi:10.1164/rccm.200709-1356OC
© 2008 American Thoracic Society doi: 10.1164/rccm.200709-1356OC
The Effects of Fluticasone with or without Salmeterol on Systemic Biomarkers of Inflammation in Chronic Obstructive Pulmonary Disease1 Department of Medicine (Respiratory Division), University of British Columbia, Vancouver, Canada; 2 Department of Medicine, University of Saskatchewan, Saskatoon, Canada; 3 Department of Medicine, University of Calgary, Calgary, Canada; 4 Department of Medicine, University of Alberta, Edmonton, Canada; 5 Wetaskiwin General Hospital, Wetaskiwin, Canada; 6 Lions Gate Hospital, North Vancouver, Canada; 7 Royal Alexandra Hospital, Edmonton, Canada; 8 Grey Nuns Hospital, Edmonton, Canada; 9 Lethbridge General Hospital, Lethbridge, Canada; and 10 Matsqui-Sumas-Abbotsford General Hospital, Abbotsford, Canada Correspondence and requests for reprints should be addressed to S. F. Paul Man, M.D., Room 548, Burrard Building, St. Paul's Hospital, 1081 Burrard Street, Vancouver, BC, V6Z 1Y7 Canada. E-mail: pman{at}providencehealth.bc.ca 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 β2-adrenergic agonist on systemic biomarkers of inflammation. Methods: We conducted a double-blind randomized placebo-controlled trial across 11 centers (n = 289 patients with FEV1 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. FEV1 improved significantly only in the fluticasone/salmeterol group compared with placebo. Conclusions: ICS in conjunction with long-acting β2-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. Clinical trial registered with www.clinicaltrials.gov (NCT 00120978).
Key Words: systemic inflammation • placebo • fluticasone • salmeterol
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