title: Analysis of montelukast in mild persistent asthmatic patients with near-normal lung function.
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 beta-agonist use were included as four cohorts (A, B, C, D), and efficacy measures, including change in FEV1 rescue-free days, beta-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 FEV1 ranged from 81% to 84% predicted and daily beta-agonist use from 2.4 to 4.5 puffs day(-1) in 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 FEV1 in montelukast-treated patients (7-8% over baseline) compared with placebo (1-4% over baseline, between-group difference P < or = 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.
authors.affiliation: Department of Respiratory Medicine, London Chest Hospital, UK. neil.barnes@bartsandthelondon.nhs.uk
authors.forename: N
authors.initials: N
authors.lastname: Barnes
authors.forename: L X
authors.initials: LX
authors.lastname: Wei
authors.forename: T F
authors.initials: TF
authors.lastname: Reiss
authors.forename: J A
authors.initials: JA
authors.lastname: Leff
authors.forename: S
authors.initials: S
authors.lastname: Shingo
authors.forename: C
authors.initials: C
authors.lastname: Yu
authors.forename: J M
authors.initials: JM
authors.lastname: Edelman
mesh_terms: D000085:Acetates / Q000627:therapeutic use*; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D003521:Cyclopropanes; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004804:Eosinophils; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D011804:Quinolines / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D013440:Sulfides; D016896:Treatment Outcome
chemical_list: D000085:Acetates; D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; C093875:montelukast