Attenuation of the September Epidemic of Asthma Exacerbations in Children: A Randomized, Controlled Trial of Montelukast Added to Usual Therapy

Abstract

Johnston N, Mandhane P, Dai J, et al. Pediatrics. 2007;120(3). Available at: www.pediatrics.org/cgi/content/full/120/3/e702 PURPOSE OF THE STUDY. To evaluate whether montelukast, when added to usual asthma therapy, would affect the asthma symptoms experienced during the annual asthma epidemic occurring each year when school resumes after summer vacation. STUDY POPULATION. Participants included 194 subjects from 2 to 14 years of age with physician-diagnosed asthma. More than 90% of the children had prescriptions for an inhaled corticosteroid (ICS). METHODS. Children were randomly assigned to receive either an age-appropriate dose of montelukast (n = 98) or placebo (n = 96). The first tablet was taken the evening of September 1 and continued nightly for 45 days. Asthma symptoms, cold symptoms, use of oral prednisone, and unscheduled physician visits resulting from asthma were recorded daily. Subjects were instructed to take the tablet in addition to their usual asthma therapy. RESULTS. Children who received montelukast experienced 53% fewer days with “worse asthma symptoms” compared with children who received placebo (3.9% vs 8.3%; P < .02). In addition, there was a 78% reduction in the number of unscheduled visits to a physician for asthma (4 vs 18; P = .011). These improvements were seen in patients with and without cold symptoms. Among boys, the greatest benefit from montelukast was seen in those aged 2 to 5 years. Girls benefited most from montelukast when they were between the ages of 10 and 14 years. CONCLUSIONS. Montelukast, when added to usual asthma therapy, reduced the risk of worsening asthma symptoms and unscheduled physician visits during the annual September asthma epidemic. REVIEWER COMMENTS. It has long been recognized that epidemics of asthma exacerbations occur annually after students return to school after summer vacation. This study demonstrates that montelukast, a leukotriene-receptor antagonist, could be used in conjunction with usual asthma medications to attenuate some of these annual symptoms. The study population enrolled in this study was composed largely of persistently asthmatic children, based on the fact that >90% were prescribed ICSs. Additional studies are needed to investigate whether a similar reduction in asthma symptoms would be seen in subjects with less-severe asthma. In addition, compliance with the use of prescribed ICS in this study was relatively poor, with only 47% of subjects using an ICS routinely. This is in agreement with other studies that have shown that ICS prescription filling is at its lowest just before the return to school. It remains to be seen whether simply improving compliance with prescribed ICSs at the start of the academic school year would also lead to a significant reduction in asthma symptoms.