The Back to School Asthma Study: The Effect of Montelukast on Asthma Burden When Initiated Prophylactically at the Start of the School Year

METHODS. This was a randomized, multicenter, doubleblind, 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 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 -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 agonist or leukotriene receptor antagonist within 10 days of randomization were also excluded.