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

Few studies have specifically evaluated controller therapy in patients with mild persistent asthma. We used a subgroup analysis to investigate the eff ects 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 ad ult 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% > 75% predicted or further restricted by less than dail y 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. Coho rts A to D comprised 21%, 8%, 11%. and 4%. respectively, of patients from t hese studies. Mean pretreatment FEV1 ranged from 81% to 84% predicted and d aily beta -agonist use from 2(.)4 to 4(.)5 puffs day(-1) in the four cohort s, pooled results demonstrated a treatment effect for montelukast over plac ebo 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 less than or equal t o0(.)02) for all cohorts. Similarly, the percentage of rescue-free days inc reased substantially more with montelukast P less than or equal to0.02) tha n with placebo (8-13%). This subgroup analysis indicates that montelukast p roduced improvements in parameters of asthma control in patients with milde r persistent asthma that should be confirmed in additional prospective tria ls.