Asthma and lower airway diseaseOmalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma
Section snippets
Patients
Patients were boys or girls age 6 to <12 years with moderate-to-severe allergic (IgE-mediated) asthma.27 Patients had inadequately controlled asthma despite receiving at least medium doses of ICS (≥200 μg/d fluticasone propionate via dry powder inhaler or equivalent).27 They had daytime or nighttime symptoms, demonstrated an increase of ≥12% in FEV1 after 4 puffs (4 × 100 μg) or up to 5 mg nebulized albuterol, and had a history of exacerbations (≥2 within 1 year, ≥3 within 2 years, or ≥1 severe
Patient disposition and baseline characteristics
Of the 1443 children screened, 627 children who remained symptomatic during the last 4 weeks of run-in were treated with omalizumab (n = 421) or placebo (n = 206; Fig 1). In the placebo group, 1 additional patient was not randomized and was therefore excluded from the ITT population but included in the safety population (n = 207). The mITT population included 576 patients.
Patient demographic and baseline clinical characteristics were well balanced between treatment groups. The mean age was 8.6
Discussion
This randomized, double-blind, placebo-controlled study in children with moderate-to-severe allergic (IgE-mediated) asthma demonstrates that add-on omalizumab significantly reduces clinically significant asthma exacerbations. The study also demonstrated that omalizumab has an acceptable safety profile and is well tolerated.
Compared with placebo, omalizumab reduced clinically significant exacerbations by 31% during the 24-week fixed-steroid phase. Over the 52-week treatment period, efficacy was
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Supported by Novartis Pharma AG.
Disclosure of potential conflict of interest: B. Lanier has served as a consultant for Alcon Laboratories and has received research support from Alcon Laboratories, Genentech/Novartis, and AstraZeneca. T. Bridges has served on the speakers' bureau and has received research support from Novartis and Genentech. The rest of the authors have declared that they have no conflict of interest.
ClinicalTrials.gov Identifier: NCT00079937