Effect of montelukast for treatment of asthma in cigarette smokers

David Price* (Corresponding Author), Todor A. Popov, Leif Bjermer, Susan Lu, Romana Petrovic, Kristel Vandormael, Anish Mehta, Jolanta D. Strus, Peter G. Polos, George Philip

*Corresponding author for this work

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

Objective: 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 μg 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 μg of fluticasone propionate twice daily significantly increased the mean percentage of days with asthma control compared with placebo.
Original languageEnglish
Pages (from-to)763-771.e6
Number of pages15
JournalJournal of Allergy and Clinical Immunology
Volume131
Issue number3
Early online date4 Feb 2013
DOIs
Publication statusPublished - Mar 2013

Keywords

  • Montelukast
  • smoking
  • fluticasone propionate
  • leukotriene receptor antagonist
  • asthma control
  • corticosteroids

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    Price, D., Popov, T. A., Bjermer, L., Lu, S., Petrovic, R., Vandormael, K., Mehta, A., Strus, J. D., Polos, P. G., & Philip, G. (2013). Effect of montelukast for treatment of asthma in cigarette smokers. Journal of Allergy and Clinical Immunology, 131(3), 763-771.e6. https://doi.org/10.1016/j.jaci.2012.12.673