Published ahead of print on December 12, 2002, doi:10.1164/rccm.200208-783OC Am. J. Respir. Crit. Care Med., Volume 167, Number 5, March 2003, 745-750 A more recent version of this article appeared on March 1, 2003
Submitted on August 2, 2002 Effect of the addition of montelukast to inhaled fluticasone propionate on airway inflammationSiobhan O' Sullivan1*,1 Clinical Immunology, Royal Free and University College School of Medicine, London, London, United Kingdom, 2 Research and Development, GlaxoSmithKline, Uxbridge, London, United Kingdom, 3 Dept of Respiratory Medicine, James Connolly Memorial Hospital, Blanchardstown, Dublin, Ireland * To whom correspondence should be addressed. 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 (100µg bid) on airway immunopathology in mild asthmatics. Twenty-eight subjects received FP (100µg bid) or FP (100µg bid) plus montelukast (10mg nocte) for eight weeks and were then crossed over to the alternate treatment for a further eight weeks. Physiological measurements and bronchial biopsies were obtained at ± 2 days prior to treatment and ± 2 days at the end of each treatment period. A two-period cross-over analysis was performed and the mean and standard error 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 eight 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- Key words: montelukast, fluticasone propionate, inflammation, biopsy
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(p=0.76) or IL-4 (p=0.61) between treatments. Reduction of inflammatory cell numbers in the bronchial mucosa achieved with FP plus montelukast was not significantly different to the reduction observed with FP alone in mild asthmatics.
