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Published ahead of print on February 28, 2008, doi:10.1164/rccm.200709-1356OC

Am. J. Respir. Crit. Care Med., Volume 177, Number 11, June 2008, 1207-1214

A more recent version of this article appeared on June 1, 2008
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Submitted on September 12, 2007
Accepted on March 6, 2008

The Effects of Fluticasone With or Without Salmeterol On Systemic Biomarkers of Inflammation in COPD

Don D Sin1, Shu-Fan P Man1*, Darcy D Marciniuk2, Gordon Ford3, Mark FitzGerald1, Eric Wong4, Ernest York5, Rajesh R Mainra6, Warren Ramesh7, Lyle S Melenka8, Eric Wilde9, Robert L Cowie3, Dave Williams10, Wen Q Gan1, Roxanne Rousseau1, and On behalf of the ABC (Advair, Biomarkers in COPD) Investigators11

1 Department of Medicine (Respiratory Division), University of British Columbia, Vancouver, BC, Canada, 2 Department of Medicine, University of Saskatchewan, Saskatoon, SK, Canada, 3 Department of Medicine, University of Calgary, Calgary, AB, Canada, 4 Department of Medicine, University of Alberta, Edmonton, AB, Canada, 5 Department of Medicine, Wetaskiwin General Hospital, Wetaskiwin, AB, Canada, 6 Department of Medicine, Lions Gate Hospital, North Vancouver, BC, Canada, 7 Department of Medicine, Royal Alexandra Hospital, Edmonton, AB, Canada, 8 Department of Medicine, Grey Nuns Hospital, Edmonton, AB, Canada, 9 Department of Medicine, Lethbridge General Hospital, Lethbridge, AB, Canada, 10 Department of Medicine, Matsqui-Sumas-Abbotsford General Hospital, Abbottsford, BC, Canada, 11 ABC (Advair, Biomarkers in COPD) Investigators, none

* To whom correspondence should be addressed. 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). OJBECTIVE: To determine the effect of inhaled corticosteroids (ICS) with or without long-acting {beta}2 adrenergic agonist (LABA) on systemic biomarkers of inflammation. METHODS: We conducted a double blind randomized placebo control 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 end point was C-reactive protein (CRP). Secondary molecules of interest were interleukin-6 (IL-6) and surfactant protein D (SPD). 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 SPD 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 SPD 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 LABA do not reduce CRP or IL-6 levels in serum of COPD patients over 4 weeks. They do, however, significantly reduce serum SPD levels. These data suggest that these drugs reduce lung-specific but not generalized biomarkers of systemic inflammation in COPD. Clinical trials registration available at www.clinicaltrials.gov i.d. NCT00120978
Key words: randomized controlled trial; systemic inflammation; COPD




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