Effects of montelukast treatment on clinical and inflammatory variables in patients with cystic fibrosis

Background In cystic fibrosis (CF), the inflammatory process contributes to progressive lung tissue damage. Cysteinyl leukotrienes have been found in the sputum of patients with CF at high concentrations sufficient to cause potent biological effects. Objective To evaluate the effect of anti-inflammatory treatment with montelukast sodium in patients with CF. Methods Twenty-six patients aged 6 to 18 years were recruited to this 20-week, randomized, double-blind, placebo-controlled, crossover trial. Patients received montelukast or placebo for 8 weeks in addition to their regular CF treatment. Before and after treatment, findings from spirometry, whole-body plethysmography, and the clinical wheezing and cough scales were evaluated. At the same time, serum and sputum samples were obtained for the measurement of eosinophil cationic protein, interleukin 10 (IL-10), IL-8, and myeloperoxidase levels. Results Twenty-three patients completed the study. Compared with placebo use, montelukast treatment significantly improved forced expiratory volume in 1 second, peak expiratory flow, and forced expiratory flow between 25% and 75% and significantly decreased cough and wheezing scale scores ( P P Conclusions Montelukast may have measurable anti-inflammatory properties in patients with CF.