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QUESTION: In children with asthma, does continuous, long term treatment with budesonide or nedocromil improve lung function
Design
Randomised {allocation concealed*}†, {partially blinded (active treatment v placebo was blinded, but mode of treatment [steroid v non-steroid] was not)}†,* controlled trial with mean 4.3 years of follow up.
Setting
8 clinical centres in the US and Canada.
Patients
1041 children who were 5–12 years of age (mean age 9 y, 60% boys), had mild to moderate asthma, and had no other clinically significant condition. Follow up was 98% for lung function and ≥86% for diary outcomes.
Intervention
Patients were allocated to 1 of 2 active agents or a matching placebo. Active agents were budesonide, 200 μg twice daily in two 100 μg puffs from a metered dose inhaler …
Footnotes
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Sources of funding: National Heart, Lung, and Blood Institute and National Center for Research Resources. Drugs were provided by AstraZeneca; Glaxo Research Institute; Rhone-Poulenc Rorer.
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For correspondence: Dr J Tonascia, CAMP Coordinating Center, Johns Hopkins University, 615 North Wolfe Street, Room 5010, Baltimore, MD 21205, USA.
↵† Information provided by author.