Investigators from the Hospital for Sick Children, University of Toronto in Toronto, Canada conducted a randomized, double-blind trial to determine the efficacy of using montelukast instead of prednisone/prednisolone in the outpatient stabilization of children following an episode of acute asthma. The study group consisted of a convenience sample of children 2 to 17 years of age selected from 2,216 children seen in the emergency department (ED) with acute asthma between September 2005 and February 2008. Children with a mild to moderate exacerbation defined as a baseline Pediatric Respiratory Assessment Measure score of <8 points1 and a Pulmonary Index score of <11 points2 were eligible. Children previously hospitalized, without respiratory distress, or without a history of wheezing or bronchodilator therapy were excluded, as were children who had received more than a single dose of prednisone/prednisolone or >250 mcg/day of inhaled fluticasone within 72 hours, or had received montelukast within seven days.
All eligible children were initially treated with oral prednisone or prednisolone and nebulized albuterol with ipratropium in saline. After stabilization, patients were randomized to receive prednisone/prednisolone or montelukast in appropriate age-related doses at 24, 48, 72, 96, and 120 hours after randomization. They were also instructed to take 500 mcg of albuterol via a metered-dose inhaler (MDI) every four hours as needed for five more days and 100 mcg of fluticasone twice a day via MDI on day seven for four additional weeks. The primary outcome measure was treatment failure, defined as an unscheduled asthma-related visit, hospitalization, or need for additional systemic corticosteroids within eight days of the original ED visit.
Of 134 children randomized, 130 completed the study and were included in the primary analysis, 63 in the prednisone/prednisolone group and 67 in the montelukast group. Mean age was 5 years. Treatment failure occurred in 5 of 63 patients in the prednisone/prednisolone group (7.9%) and 15 of 67 (22.4%) in the montelukast group (95% CI for difference between the groups, −26.5% to −2.4%). All children experiencing treatment failure underwent asthma-related unscheduled medical visits. None were hospitalized. Patients between 2 and 3 years of age were approximately five times as likely to return for care as their older counterparts.
The authors conclude that because montelukast in the acute asthma post-stabilization period resulted in a higher rate of treatment failure compared with prednisone/prednisolone, children presenting to the ED with mild to moderate acute asthma should be treated with oral steroids in preference to montelukast.
Of the approximately five million children in the US with acute asthma,3 most have disease of mild to moderate severity1 and are treated with a course of oral corticosteroid for five to seven days at home.3,4 Montelukast blocks the pro-inflammatory effects of...