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QUESTION: In children with moderate to severe allergic asthma who require daily inhaled corticosteroid (ICS) treatment, is omalizumab (anti-immunoglobulin E [anti-IgE] antibody) more effective than placebo for reducing steroid use and asthma exacerbations?
Design
Randomised {allocation concealed*}†, blinded (clinicians, patients {outcome assessors, and statisticians}†,)* placebo controlled trial with 34 weeks of follow up.
Setting
Research centres in 12 US states and in Washington, DC.
Patients
334 asthmatic patients who were 6 to 12 years of age (mean age 9 y, 69% boys) and whose asthma was well controlled with ICSs (beclomethasone dipropionate [BDP] and bronchodilator treatment) for ≥ 3 months before randomisation. Other inclusion criteria were allergic asthma for ≥ 1 year; positive skin prick test result to ≥ 1 of house dust mite, cockroach, dog, or cat; total serum IgE level between 30 …
Footnotes
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Sources of funding: Genentech, Inc. and Novartis Pharmaceuticals Corporation.
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For correspondence: Dr H Milgrom, National Jewish Medical and Research Center, 1400 Jackson Street, Denver, CO 80206, USA. milgromh{at}njc.org
↵† Information provided by author.