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QUESTION: In children with persistent asthma, is montelukast a well tolerated and effective therapeutic option?
Design
Randomised {allocation concealed*}†, blinded (patients, clinicians, and {data collectors}†),* placebo controlled trial with 12 weeks of follow up.
Setting
93 centres in Africa, Australia, Europe, North America, and South America.
Patients
689 children who were 2 to 5 years of age (mean age 4 y, 59% boys, 56% white), had ≥ 3 episodes of asthma symptoms in the previous year, had a total asthma symptom score ≥ 1 (of 24) for ≥ 8 days during the 2 week placebo baseline period, and used β agonists for ≥ 8 days during the placebo baseline period. Exclusion criteria included asthma intubation and emergency department treatment or admission …
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