title: Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations.
abstract: 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 (clincaltrials.gov #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.
authors.affiliation: Division of Emergency Medicine and the Department of Pediatrics, Children's National Health System, Washington, DC. Electronic address: steach@childrensnational.org.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Teach
authors.affiliation: Departments of Pediatrics and Immunology, University of Texas Southwestern Medical Center, Dallas, Tex.
authors.forename: Michelle A
authors.initials: MA
authors.lastname: Gill
authors.affiliation: National Institute of Allergy and Infectious Diseases, Bethesda, Md.
authors.forename: Alkis
authors.initials: A
authors.lastname: Togias
authors.affiliation: University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: Christine A
authors.initials: CA
authors.lastname: Sorkness
authors.affiliation: Rho Inc, Federal Systems Division, Chapel Hill, NC.
authors.forename: Samuel J
authors.initials: SJ
authors.lastname: Arbes
authors.affiliation: Rho Inc, Federal Systems Division, Chapel Hill, NC.
authors.forename: Agustin
authors.initials: A
authors.lastname: Calatroni
authors.affiliation: Rho Inc, Federal Systems Division, Chapel Hill, NC.
authors.forename: Jeremy J
authors.initials: JJ
authors.lastname: Wildfire
authors.affiliation: National Institute of Allergy and Infectious Diseases, Bethesda, Md.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Gergen
authors.affiliation: Boston University School of Medicine, Boston, Mass.
authors.forename: Robyn T
authors.initials: RT
authors.lastname: Cohen
authors.affiliation: Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.
authors.forename: Jacqueline A
authors.initials: JA
authors.lastname: Pongracic
authors.affiliation: Cincinnati Children's Hospital, Cincinnati, Ohio.
authors.forename: Carolyn M
authors.initials: CM
authors.lastname: Kercsmar
authors.affiliation: Cincinnati Children's Hospital, Cincinnati, Ohio.
authors.forename: Gurjit K
authors.initials: GK
authors.lastname: Khurana Hershey
authors.affiliation: Departments of Pediatrics and Immunology, University of Texas Southwestern Medical Center, Dallas, Tex.
authors.forename: Rebecca S
authors.initials: RS
authors.lastname: Gruchalla
authors.affiliation: National Jewish Health, Denver, Colo; Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, Colo.
authors.forename: Andrew H
authors.initials: AH
authors.lastname: Liu
authors.affiliation: Department of Internal Medicine, Division of Allergy and Immunology, Henry Ford Hospital, Detroit, Mich.
authors.forename: Edward M
authors.initials: EM
authors.lastname: Zoratti
authors.affiliation: College of Physicians and Surgeons, Columbia University, New York, NY.
authors.forename: Meyer
authors.initials: M
authors.lastname: Kattan
authors.affiliation: University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: Kristine A
authors.initials: KA
authors.lastname: Grindle
authors.affiliation: University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: James E
authors.initials: JE
authors.lastname: Gern
authors.affiliation: University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: William W
authors.initials: WW
authors.lastname: Busse
authors.affiliation: Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, Colo.
authors.forename: Stanley J
authors.initials: SJ
authors.lastname: Szefler
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000009:adverse effects / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000276:immunology; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016898:Interferon-alpha / Q000276:immunology; D007963:Leukocytes, Mononuclear / Q000276:immunology / Q000821:virology; D008297:Male; D000069444:Omalizumab / Q000009:adverse effects / Q000627:therapeutic use*; D012229:Rhinovirus; D012621:Seasons
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D016898:Interferon-alpha; D000069444:Omalizumab
keywords: Asthma; IFN-α; asthma exacerbations; fall season; inhaled corticosteroid; omalizumab; rhinovirus