Evidence map›Paper›PMID 21410369›Full record

Trial reportThe New England journal of medicine2011

Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children.

William W Busse, Wayne J Morgan, Peter J Gergen, Herman E Mitchell, James E Gern, Andrew H Liu, Rebecca S Gruchalla, Meyer Kattan, Stephen J Teach, Jacqueline A Pongracic and 7 more

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 393 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
393citing papers in PubMed, 11 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00377572 phase4completednot on this map

Inner-City Anti-IgE Therapy for Asthma (ICAC-08)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2006 to 2009Enrolled419ConditionsAsthmaArmsomalizumab, omalizumab placebo
NCT03926741 early_phase1completednot on this mapstarted 2019, after this paper: background citation

Methods to Identify and Treat Severe Asthma Patients Project 1: GSNOR Phenotyping and GSNO Challenge

TypeinterventionalSponsorJames ReynoldsRan2019 to 2024Enrolled48ConditionsAsthmaArmsGSNO Challenge
3 · Its place in the literature

Who cites it

393 citing papers in PubMed, 11 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Safety of biologics for the treatment of asthma in children and adolescents: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2025
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Guideline
  10. Pooled it
  11. Interventions for autumn exacerbations of asthma in children.The Cochrane database of systematic reviews · 2018
    Pooled it
  12. Trial
  13. Trial
  14. Trial
  15. Lower viral loads in subjects with rhinovirus-challenged allergy despite reduced innate immunity.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2022
    Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

333 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

William W BusseDepartment of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53719, USA. wwb@medicine.wisc.edu
Wayne J Morgan
Peter J Gergen
Herman E Mitchell
James E Gern
Andrew H Liu
Rebecca S Gruchalla
Meyer Kattan
Stephen J Teach
Jacqueline A Pongracic
James F Chmiel
Suzanne F Steinbach
Agustin Calatroni
Alkis Togias
Katherine M Thompson
Stanley J Szefler
Christine A Sorkness

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024156 · NCRR · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2006 to 2011
$53.0M
ZIPRASIDONE (GEODON) AUGMENTATION IN SEROTONIN REUPTAKE INHIBITOR-RESISTANT OBM01RR000071 · NCRR · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI OHNUMA, TAKAO · 1985 to 2009
$41.5M
Training (Career Development) ComponentU54HD061221 · NICHD · CHILDREN'S RESEARCH INSTITUTE · PI NAGAMANI, SANDESH CHAKRAVARTHY SREENATH · 2009 to 2023
$20.8M
YOGA INDUCED CHANGES IN BRAIN GABA LEVELSM01RR000533 · NCRR · BOSTON UNIVERSITY MEDICAL CAMPUS · PI ANTMAN, KAREN · 1985 to 2008
$19.4M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025771 · NCRR · BOSTON UNIVERSITY MEDICAL CAMPUS · PI CENTER, DAVID M. · 2008 to 2011
$17.6M
Translational Research in Cystic FibrosisP30DK027651 · NIDDK · CASE WESTERN RESERVE UNIVERSITY · PI DRUMM, MITCHELL L · 1986 to 2014
$15.6M
ZAP-70 EXPRESSION, CD38 EXPRESSION AND PROGNOSIS IN CHRONIC LYMPHOCYTIC LEUKEMIAM01RR020359 · NCRR · CHILDREN'S RESEARCH INSTITUTE · PI RAKHMANINA, NATELLA Y · 2005 to 2010
$13.8M
Inner-City Asthma Consortium-266025496-266025496N01AI025496 · NIAID · UNIVERSITY OF WISCONSIN · PI BUSSE, WILLIAM · 2002 to 2006
–
NCRR NIH HHS 1UL1RR024156NCRR NIH HHS 1UL1RR025771NCRR NIH HHS 5M01RR020359-040NCRR NIH HHS M01 RR000071NCRR NIH HHS M01 RR000533NCRR NIH HHS M01RR00071NCRR NIH HHS M01RR00533NCRR NIH HHS M01 RR020359NCRR NIH HHS UL1 RR024156NCRR NIH HHS UL1 RR025771NIAID NIH HHS N01 AI025482NIAID NIH HHS N01 AI025496NIAID NIH HHS N01-AI-25482NIAID NIH HHS N01-AI-25496NICHD NIH HHS U54 HD061221NIDDK NIH HHS P30 DK027651
6 · The paper itself

Abstract

backgroundResearch 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.

methodsWe 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.

resultsAmong 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.

conclusionsWhen 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.).

Indexed as

Administration, InhalationAnimalsAnti-Asthmatic AgentsAntibodies, Anti-IdiotypicAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAsthmaChildCockroachesDouble-Blind MethodDrug Therapy, CombinationDustFemaleGlucocorticoidsHumansImmunoglobulin EAnti-Asthmatic AgentsAntibodies, Anti-IdiotypicAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedanti-IgE antibodiesDustGlucocorticoidsImmunoglobulin EOmalizumab

Identifiers

PMID21410369
PMCPMC3093964

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.