Regular Article
Analysis of montelukast in mild persistent asthmatic patients with near-normal lung function

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Abstract

Few studies have specifically evaluated controller therapy in patients with mild persistent asthma. We used a subgroup analysis to investigate the effects of montelukast, a potent cysteinyl leukotriene receptor antagonist, on adult patients on the milder end of the asthma severity spectrum. We have identified seven double-blind, randomized, placebo-controlled studies of adult patients with mild-to-moderate chronic asthma in which montelukast was investigated. Subsets of patients with baseline forced expiratory volume in 1 sec (FEV1) >80% and >75% predicted or further restricted by less than daily rescue β -agonist use were included as four cohorts (A, B, C, D), and efficacy measures, including change in FEV1rescue-free days, β -agonist use, nocturnal awakenings and blood eosinophil counts were evaluated. Cohorts A to D comprised 21%, 8%, 11%, and 4%, respectively, of patients from these studies. Mean pretreatment FEV1ranged from 81% to 84% predicted and daily β -agonist use from 2·4 to 4·5 puffs day−1in the four cohorts. Pooled results demonstrated a treatment effect for montelukast over placebo in all cohorts, for all endpoints. There was a significant improvement in FEV1in montelukast-treated patients (7–8% over baseline) compared with placebo (1–4% over baseline, between-group difference P≤0·02) for all cohorts. Similarly, the percentage of rescue-free days increased substantially more with montelukast (22–30%) than with placebo (8–13%). This subgroup analysis indicates that montelukast produced improvements in parameters of asthma control in patients with milder persistent asthma that should be confirmed in additional prospective trials.

Keywords

mild persistent asthma
cysteinyl leukotriene receptor antagonist
montelukast
pulmonary function
rescue-free day
treatment guidelines.

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This study was supported by a grant from Merck Research Laboratories.

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Correspondence should be addressed to: Neil Barnes, Department of Respiratory Medicine, London Chest Hospital, Bonner Road, London E2 9JX, U.K. Fax: +44-20-8983-2279; E-mail: [email protected]