title: Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children.
abstract: BACKGROUND
  Research has underscored the effects of exposure and sensitization to allergens on the severity of asthma in inner-city children. It has also revealed the limitations of environmental remediation and guidelines-based therapy in achieving greater disease control.
  
  
  METHODS
  We enrolled inner-city children, adolescents, and young adults with persistent asthma in a randomized, double-blind, placebo-controlled, parallel-group trial at multiple centers to assess the effectiveness of omalizumab, as compared with placebo, when added to guidelines-based therapy. The trial was conducted for 60 weeks, and the primary outcome was symptoms of asthma.
  
  
  RESULTS
  Among 419 participants who underwent randomization (at which point 73% had moderate or severe disease), omalizumab as compared with placebo significantly reduced the number of days with asthma symptoms, from 1.96 to 1.48 days per 2-week interval, a 24.5% decrease (P<0.001). Similarly, omalizumab significantly reduced the proportion of participants who had one or more exacerbations from 48.8 to 30.3% (P<0.001). Improvements occurred with omalizumab despite reductions in the use of inhaled glucocorticoids and long-acting beta-agonists.
  
  
  CONCLUSIONS
  When added to a regimen of guidelines-based therapy for inner-city children, adolescents, and young adults, omalizumab further improved asthma control, nearly eliminated seasonal peaks in exacerbations, and reduced the need for other medications to control asthma. (Funded by the National Institute of Allergy and Infectious Diseases and Novartis; ClinicalTrials.gov number, NCT00377572.).
authors.affiliation: Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53719, USA. wwb@medicine.wisc.edu
authors.forename: William W
authors.initials: WW
authors.lastname: Busse
authors.forename: Wayne J
authors.initials: WJ
authors.lastname: Morgan
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Gergen
authors.forename: Herman E
authors.initials: HE
authors.lastname: Mitchell
authors.forename: James E
authors.initials: JE
authors.lastname: Gern
authors.forename: Andrew H
authors.initials: AH
authors.lastname: Liu
authors.forename: Rebecca S
authors.initials: RS
authors.lastname: Gruchalla
authors.forename: Meyer
authors.initials: M
authors.lastname: Kattan
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Teach
authors.forename: Jacqueline A
authors.initials: JA
authors.lastname: Pongracic
authors.forename: James F
authors.initials: JF
authors.lastname: Chmiel
authors.forename: Suzanne F
authors.initials: SF
authors.lastname: Steinbach
authors.forename: Agustin
authors.initials: A
authors.lastname: Calatroni
authors.forename: Alkis
authors.initials: A
authors.lastname: Togias
authors.forename: Katherine M
authors.initials: KM
authors.lastname: Thompson
authors.forename: Stanley J
authors.initials: SJ
authors.lastname: Szefler
authors.forename: Christine A
authors.initials: CA
authors.lastname: Sorkness
mesh_terms: D000280:Administration, Inhalation; D000818:Animals; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D003058:Cockroaches / Q000276:immunology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004391:Dust / Q000032:analysis; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D008297:Male; D000069444:Omalizumab; D011204:Poverty Areas; D017410:Practice Guidelines as Topic; D012621:Seasons; D014505:Urban Population
chemical_list: D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D004391:Dust; D005938:Glucocorticoids; C026408:anti-IgE antibodies; D000069444:Omalizumab; D007073:Immunoglobulin E