Lansoprazole for Children With Poorly Controlled Asthma: A Randomized Controlled Trial Writing Committee for the American Lung Association

RESULTS. Almost 600 patients were randomized to each treatment arm. Almost 75% of patients had a least 1 episode of asthma, with almost half of patients culminating in an exacerbation. No significant difference was seen between groups in the number of episodes leading to asthma exacerbations. Daily montelukast reduced symptoms over the 12-day treatment period of asthma episodes compared with placebo (P 5 .045). b-Agonist use was reduced with both daily (P 5 .048) and intermittent (P 5 .028) montelukast compared with placebo. However, because of prespecified rules for multiplicity adjustments (requiring a positive primary endpoint), statistical significance for secondary endpoints could not be concluded.