Evaluation of montelukast in 8 to 14 year old children with mild persistent asthma and compared with inhaled corticosteroids.

OBJECTIVES To determine the clinical effectiveness, tolerability and reliability of montelukast and to compare this drug with inhaled corticosteroids. METHODS We performed a randomized, 14-week, 2-period, prospective parallel group study. After a 2-week run-in period, patients received treatment for 12 weeks. Sixty-three clinically stable outpatients aged 8 to 14 years with a history of mild persistent asthma for at least 1 year and a forced expiratory volume in one second (FEV1) greater than 80 % of the predicted value were evaluated. RESULTS Montelukast produced improvement in airway obstruction, daily symptom scores, total daily as-needed beta-agonist use, nocturnal awakenings, percentage of days and percentage of patients with asthma exacerbations, and urinary leukotriene E4 levels. These beneficial effects were similar to those produced by inhaled corticosteroids. There were no significant adverse effects requiring treatment discontinuation. CONCLUSIONS Montelukast may be a well-tolerated and effective therapeutic option in 8 to 14-year-old patients with mild persistent asthma.