Effect of montelukast for treatment of asthma in cigarette smokers - 27/02/13
, Todor A. Popov, MD b, Leif Bjermer, MD c, Susan Lu, PharmD d, Romana Petrovic, MS d, Kristel Vandormael, MS d, Anish Mehta, BA d, Jolanta D. Strus, MD d, Peter G. Polos, MD d, George Philip, MD d
Corresponding author: David Price, MD, Centre of Academic Primary Care, University of Aberdeen, Foresterhill Health Centre, Westburn Road, Aberdeen AB25 2AY, United Kingdom.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.
Le texte complet de cet article est disponible en PDF.Key words : Montelukast, smoking, fluticasone propionate, leukotriene receptor antagonist, asthma control, corticosteroids
Abbreviations used : AE, COPD, FVC, PEF, SABA
Plan
| Supported by Merck Sharp & Dohme Corp, Whitehouse Station, NJ. |
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| Disclosure of potential conflict of interest: D. Price has received consulting fees and travel support from Merck; has received consultancy fees from Boehringer Ingelheim, GlaxoSmithKline, Mundipharma, Novartis, and Teva; has received research support from the UK National Health Service, Aerocrine, AstraZeneca, Mundipharma, Novartis, Pfizer, Teva, Chiesi, and Boehringer Ingelheim; has received lecture fees from Teva, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mundipharma, and Pfizer; has a patent with and has stock/stock options in AKL Ltd; has received payment for the development of educational presentations from Teva and AstraZeneca; has received travel support from Teva, Novartis, Boehringer Ingelheim, and Mundipharma; and is Owner of Research in Real Life Ltd. L. Bjermer is on the AstraZeneca, Almirall, GlaxoSmithKline, Boehringer Ingelheim, Mundipharma, Merck, Novartis, and Nycomed-Takeda boards and has received lecture fees from AstraZeneca, Almirall, GlaxoSmithKline, GlaxoSmithKline, Boehringer Ingelheim, Mundipharma, Merck, Nigard, Novartis, and Nycomed-Takeda. S. Lu, K. Vandormael, A. Mehta, J. D. Strus, and G. Philip are employed by and have stock/stock options in Merck. R. Petrovic was employed by Merck until 2010. P. G. Polos was employed by Merck at the time of the study. T. A. Popov declares that he has no relevant conflicts of interest. |
Vol 131 - N° 3
P. 763 - mars 2013 Retour au numéro
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