PURPOSE OF THE STUDY.
To determine the efficacy of prophylactic montelukast therapy in reducing asthma morbidity at the start of the school year.
Patients 6 to 14 years of age with a diagnosis of asthma for a minimum of 1 year were recruited for this international study that took place in 39 US states and 3 Canadian provinces from June 2006 through November 2006.
This was a randomized, multicenter, double-blind, placebo-controlled study for patients who received either 5-mg montelukast or placebo beginning on the night before school started and continued for an 8-week period. Patients were randomly assigned during a screening period from 2 to 12 weeks before the school start date. Patients were interviewed by telephone to review symptoms, use of study medications, and need for additional β agonists 4 weeks after starting school. A final study visit at 8 weeks was conducted to document daytime symptoms, “awake all night,” inhaled corticosteroid use, increased β-agonist use, and visits to a health care professional or facility for asthma. Inclusion criteria included treatment of asthma within 6 months of screening and patients having at least 1 exacerbation of asthma symptoms in the previous year that were associated with a cold. Exclusion criteria included forced expiratory flow volume in 1 second below 60% of that predicted, use of systemic steroids within 4 weeks of randomization, and more than 3 hospitalizations for asthma in the previous year. Patients on treatment with a long-acting β agonist or leukotriene receptor antagonist within 10 days of randomization were also excluded.
Of 1162 patients (580 randomly assigned to the montelukast group and 582 randomized to the placebo group), no significant difference was seen for the percentage of days with worsening asthma. A trend for montelukast to reduce worsening asthma days in those who began school after August 15 was seen but was not significant. A nonsignificant trend in older children and boys favoring treatment with montelukast was also seen.
The use of montelukast did not significantly reduce the number of days with worsening asthma when begun as prophylactic therapy at the start of the school year.
The start of the school year presents a challenge for asthmatic children, who have greater disease burden with respiratory illnesses. In the group of children treated with montelukast, the percentage of days with worsening asthma was stable, whereas this percentage increased in weeks 3 to 4 in the placebo group and subsequently decreased for the remainder of the study. Because this study did not answer the need to prevent morbidity from asthma during the fall, additional studies are needed to address this concern.
- Copyright © 2011 by the American Academy of Pediatrics