Effect of montelukast for treatment of asthma in cigarette smokers

Many asthmatic patients are unable to quit cigarettes; therefore information is needed on treatment options for smokers. This study evaluates 10 mg/d montelukast and 250 mu g of fluticasone propionate twice daily, each compared with placebo, in patients with self-reported active smoking (unable to quit) and asthma. Methods: Patients (ages 18-55 years, with asthma [>= 1 year], FEV1 of 60% to 90% of predicted value, airway reversibility [>= 12%], and self-reported active smoking [>= 0.5 to <= 2 packs per day]) were randomized (after a 3-week, single-blind, placebo, run-in period) to 1 of 3 parallel, 6-month, double-blind treatment arms. The primary efficacy end point was the percentage of days with asthma control during treatment. Adverse experiences (AEs) were also evaluated. Results: There were 347, 336, and 336 patients randomized to montelukast, fluticasone, and placebo, respectively. The mean percentage of days with asthma control over 6 months of treatment was 45% (montelukast, P < .05 vs placebo), 49% (fluticasone, P < .001 vs placebo), and 39% (placebo); the difference between montelukast and fluticasone was not significant (P = .14). Patients with a smoking history of <= 11 pack years (the median value) tended to show more benefit with fluticasone, whereas those with a smoking history of >11 pack years tended to show more benefit with montelukast. AEs occurred in similar proportions among treatment groups. Conclusions: In a population of asthmatic patients actively smoking cigarettes, both 10 mg/d montelukast and 250 mu g of fluticasone propionate twice daily significantly increased the mean percentage of days with asthma control compared with placebo. (J Allergy Clin Immunol 2013;131:763-71.)