Effect of salmeterol/fluticasone propionate on airway inflammation in COPD: a randomised controlled trial

Background: Airway inflammation in chronic obstructive pulmonary disease (COPD) is characterised by infiltration of CD8(+) T cells and CD68(+) macrophages and an increased number of neutrophils, whereas few studies have described the presence of eosinophils. Although the anti-inflammatory effects of corticosteroids in stable COPD are unclear, recent studies suggest that combination therapy could be beneficial. A study was therefore undertaken to evaluate combined salmeterol/fluticasone propionate (SFC) and fluticasone propionate (FP) alone on inflammatory cells in the airways of patients with COPD. Methods: Patients were treated in a randomised, double blind, parallel group, placebo-controlled trial with either a combination of 50 mg salmeterol and 500 mg FP twice daily (SFC, n = 19, 19 men, mean age 62 years), 500 mg FP twice daily (n = 20, 15 men, mean age 64 years) or placebo (n = 21, 17 men, mean age 66 years) for 3 months. At the start and end of treatment bronchoscopy with bronchial biopsies was performed and the numbers of CD8(+) T lymphocytes, CD68(+) macrophages, neutrophils and eosinophils were measured. Results: CD8(+) cells were significantly reduced by SFC compared with placebo (difference 298.05 cells/mm(2); 95% CI 2143.14 to 252.9; p, 0.001). Such a marked effect was not seen with FP alone (244.67 cells/mm(2); 95% CI 290.92 to 1.57; p = 0.06). CD68+ macrophages were also reduced by SFC compared with placebo ( difference 231.68 cells/ mm2; 95% CI 261.07 to 22.29; p = 0.03) but not by FP. SFC did not significantly change neutrophils and eosinophils compared with placebo. Conclusions: SFC has airway anti- inflammatory effects not seen with inhaled corticosteroids alone.