作者: Stephen J. Teach , Michelle A. Gill , Alkis Togias , Christine A. Sorkness , Samuel J. Arbes
DOI: 10.1016/J.JACI.2015.09.008
关键词: Omalizumab 、 Exacerbation 、 Intention-to-treat analysis 、 Subgroup analysis 、 Internal medicine 、 Alpha interferon 、 Adverse effect 、 Placebo 、 Medicine 、 Asthma 、 Anesthesia
摘要: Background Short-term targeted treatment can potentially prevent fall asthma exacerbations while limiting therapy exposure. Objective We sought to compare (1) omalizumab with placebo and (2) an inhaled corticosteroid (ICS) boost regard exacerbation rates when initiated 4 6 weeks before return school. Methods A 3-arm, randomized, double-blind, double placebo-controlled, multicenter clinical trial was conducted among inner-city asthmatic children aged 6 17 years 1 or more recent (clincaltrials.gov #NCT01430403). Guidelines-based continued over a 4- 9-month run-in phase 4-month intervention phase. In subset the effects of on IFN-α responses rhinovirus in PBMCs were examined. Results Before falls 2012 2013, 727 enrolled, 513 478 analyzed. The rate significantly lower versus arms (11.3% vs 21.0%; odds ratio [OR], 0.48; 95% CI, 0.25-0.92), but there no significant difference between ICS (8.4% 11.1%; OR, 0.73; 0.33-1.64). prespecified subgroup analysis, participants during phase, efficacious than both (6.4% 36.3%; 0.12; 0.02-0.64) (2.0% 27.8%; 0.05; 0.002-0.98). Omalizumab improved rhinovirus, within group, greater increases associated fewer (OR, 0.14; 0.01-0.88). Adverse events rare similar arms. Conclusions Adding school ongoing guidelines-based care youth reduces fall exacerbations, particularly those exacerbation.