Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations

Stephen J. Teach, Michelle A. Gill, Alkis Togias, Christine A. Sorkness, Samuel J. Arbes, Agustin Calatroni, Jeremy J. Wildfire, Peter J. Gergen, Robyn T. Cohen, Jacqueline A. Pongracic, Carolyn M. Kercsmar, Gurjit K. Khurana Hershey, Rebecca S. Gruchalla, Andrew H. Liu, Edward M. Zoratti, Meyer Kattan, Kristine A. Grindle, James E. Gern, William W. Busse, Stanley J. Szefler

Research output: Contribution to journalArticlepeer-review

437 Scopus citations


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) omalizumab with an inhaled corticosteroid (ICS) boost with regard to fall exacerbation rates when initiated 4 to 6 weeks before return to school. Methods A 3-arm, randomized, double-blind, double placebo-controlled, multicenter clinical trial was conducted among inner-city asthmatic children aged 6 to 17 years with 1 or more recent exacerbations ( #NCT01430403). Guidelines-based therapy was continued over a 4- to 9-month run-in phase and a 4-month intervention phase. In a subset the effects of omalizumab on IFN-α responses to rhinovirus in PBMCs were examined. Results Before the falls of 2012 and 2013, 727 children were enrolled, 513 were randomized, and 478 were analyzed. The fall exacerbation rate was significantly lower in the omalizumab versus placebo arms (11.3% vs 21.0%; odds ratio [OR], 0.48; 95% CI, 0.25-0.92), but there was no significant difference between omalizumab and ICS boost (8.4% vs 11.1%; OR, 0.73; 95% CI, 0.33-1.64). In a prespecified subgroup analysis, among participants with an exacerbation during the run-in phase, omalizumab was significantly more efficacious than both placebo (6.4% vs 36.3%; OR, 0.12; 95% CI, 0.02-0.64) and ICS boost (2.0% vs 27.8%; OR, 0.05; 95% CI, 0.002-0.98). Omalizumab improved IFN-α responses to rhinovirus, and within the omalizumab group, greater IFN-α increases were associated with fewer exacerbations (OR, 0.14; 95% CI, 0.01-0.88). Adverse events were rare and similar among arms. Conclusions Adding omalizumab before return to school to ongoing guidelines-based care among inner-city youth reduces fall asthma exacerbations, particularly among those with a recent exacerbation.

Original languageEnglish
Pages (from-to)1476-1485
Number of pages10
JournalJournal of Allergy and Clinical Immunology
Issue number6
StatePublished - Dec 1 2015


  • Asthma
  • IFN-α
  • asthma exacerbations
  • fall season
  • inhaled corticosteroid
  • omalizumab
  • rhinovirus


Dive into the research topics of 'Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations'. Together they form a unique fingerprint.

Cite this