Salmeterol plus fluticasone propionate versus fluticasone propionate plus montelukast: a randomised controlled trial investigating the effects on airway inflammation in asthma

Abstract

Background: Few studies have compared treatment strategies in patients with asthma poorly controlled on low dose inhaled corticosteroids, and little is known about the effects of different treatments on airway inflammation. In this double-blind, placebo-controlled, parallel group study, we compared the effects of salmeterol plus fluticasone propionate (FP) (Seretide; SFC) and FP plus montelukast (FP/M) on sputum inflammatory markers, airway responsiveness, lung function, and symptoms in adult asthmatics.

Methods: Sixty-six subjects were randomised to SFC or FP/M for 12 weeks. The primary outcome was changes in neutrophil, eosinophil, macrophage, lymphocyte, and epithelial cell levels in induced sputum. Additional outcomes included the change in other sputum markers of airway inflammation, airway responsiveness, symptom control, and lung function.

Results: Both treatments had no significant effect on induced sputum inflammatory cells, although there was a trend for a reduction in sputum eosinophils. Both treatments significantly improved airway responsiveness, whereas SFC generally led to greater improvements in symptom control and lung function than FP/M. FP/M led to significantly greater reductions in sputum cysteinyl leukotrienes than SFC (treatment ratio 1.80; 95% CI 1.09, 2.94).

Conclusion: Both treatments led to similar control of eosinophilic airway inflammation, although PEF and symptom control were better with SFC. STUDY NUMBER: SAM40030 (SOLTA).

Figure 1

Flow of subjects through the study. FP, fluticasone propionate; n, number

Figure 2

Eosinophil count in induced sputum before and after treatment. The box is determined by the first and third quartile and the whiskers are determined by the maximum and minimum. The horizontal line represents the median value. SFC, salmeterol plus fluticasone propionate; FP/M, fluticasone propionate plus montelukast

Figure 3

Neutrophil count in induced sputum before and after treatment. The box is determined by the first and third quartile and the whiskers are determined by the maximum and minimum. The horizontal line represents the median value. SFC, salmeterol plus fluticasone propionate; FP/M, fluticasone propionate plus montelukast.