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Effect of the Addition of Montelukast to Inhaled Fluticasone Propionate on Airway Inflammation

Department of Clinical Immunology, Royal Free and University College School of Medicine, London; R&D GlaxoSmithKline, Uxbridge, United Kingdom; and Department of Respiratory Medicine, James Connolly Memorial Hospital, Dublin, Ireland

Correspondence and requests for reprints should be addressed to Siobhán O' Sullivan, Ph.D., Department of Clinical Immunology, Royal Free and University College Hospital Medical School, London NW3 2QG, UK. E-mail: sioosu{at}indigo.ie

The aim of the study was to investigate the effect of addition of montelukast to inhaled fluticasone propionate (FP) therapy, compared with FP therapy alone (100 µg twice a day) on airway immunopathology in individuals with mild asthma. Twenty-eight subjects received FP (100 µg twice a day) or FP (100 µg twice a day) plus montelukast (10 mg at night) for 8 weeks and were then crossed over to the alternate treatment for a further 8 weeks. Physiological measurements and bronchial biopsies were obtained at ± 2 days before treatment and ± 2 days at the end of each treatment period. A two-period crossover analysis was performed and the mean and SE were calculated. There was no significant difference in percent predicted FEV₁ (p = 0.51) or PC₂₀ mg/ml (p = 0.81) between the two treatment regimes after 8 weeks of therapy. There was no difference in the efficacy of either treatment in decreasing T cell (p = 0.97), CD45RO+ (p = 0.37), mast cell (p = 0.37), or activated eosinophils (p = 0.55) numbers in bronchial biopsies. There was no significant difference in the percentage area stained for IFN- (p = 0.76) or interleukin-4 (p = 0.61) between treatments. Reduction of inflammatory cell numbers in the bronchial mucosa achieved with FP plus montelukast was not significantly different from the reduction observed with FP alone in individuals with mild asthma.

Key Words: fluticasone • montelukast • inflammation • asthma

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