Trial reportThe Journal of allergy and clinical immunology2015
Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations.
Trial report in The Journal of allergy and clinical immunology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01430403 (Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations), which is not on this map. Cited by 237 papers, 10 of them syntheses that pooled 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.
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.
Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (ICAC-20)
Who cites it
237 citing papers in PubMed, 10 syntheses or guidelines pooled it, 525 citations in OpenAlex.
- Comparative efficacy and safety of biologic therapies in pediatric asthma: a comprehensive systematic review.Frontiers in medicine · 2026Pooled it
- 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 · 2025Pooled it
- Advanced Biologic Therapies in the Management of Asthma in Children and Adolescents: A Comprehensive Network Meta-Analysis.International archives of allergy and immunology · 2025Pooled it
- Biologic agents licensed for severe asthma: a systematic review and meta-analysis of randomised controlled trials.European respiratory review : an official journal of the European Respiratory Society · 2024Pooled it
- The clinical efficacy of type 2 monoclonal antibodies in eosinophil-associated chronic airway diseases: a meta-analysis.Frontiers in immunology · 2023Pooled it
- Efficacy and Safety of Omalizumab for the Treatment of Severe or Poorly Controlled Allergic Diseases in Children: A Systematic Review and Meta-Analysis.Frontiers in pediatrics · 2022Pooled it
- Considerations on biologicals for patients with allergic disease in times of the COVID-19 pandemic: An EAACI statement.Allergy · 2020Guideline
- Clinical Evidence and Biomarkers Linking Allergy and Acute or Chronic Rhinosinusitis in Children: a Systematic Review.Current allergy and asthma reports · 2020Pooled it
- The Efficacy and Evidence-Based Use of Biologics in Children and Adolescents: Using Monoclonal Antibodies and Fusion Proteins as Treatments.Deutsches Arzteblatt international · 2019Pooled it
- Interventions for autumn exacerbations of asthma in children.The Cochrane database of systematic reviews · 2018Pooled it
- COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)-a Randomized Controlled Clinical Trial.Open forum infectious diseases · 2024Trial
- Allergen Immunotherapy Enhances Airway Epithelial Antiviral Immunity in Patients with Allergic Asthma (VITAL Study): A Double-Blind Randomized Controlled Trial.American journal of respiratory and critical care medicine · 2023Trial
- Understanding the asthmatic response to an experimental rhinovirus infection: Exploring the effects of blocking IgE.The Journal of allergy and clinical immunology · 2020Trial
- A computerized decision support tool to implement asthma guidelines for children and adolescents.The Journal of allergy and clinical immunology · 2019Trial
- Non-atopic rhinitis at age 6 is associated with subsequent development of asthma.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2019Trial
- Bronchial mucosal IFN-α/β and pattern recognition receptor expression in patients with experimental rhinovirus-induced asthma exacerbations.The Journal of allergy and clinical immunology · 2019Trial
- Enhanced plasmacytoid dendritic cell antiviral responses after omalizumab.The Journal of allergy and clinical immunology · 2018Trial
- Virus-triggered exacerbation in allergic asthmatic children: neutrophilic airway inflammation and alteration of virus sensors characterize a subgroup of patients.Respiratory research · 2017Trial
- Update on Pediatric asthma management: Recent advances.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026Review
- Update on biologic and small molecules treatments in pediatric allergic diseases.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026Review
177 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
20 authors at 12 institutions in 1 country.
Funding
Abstract
backgroundShort-term targeted treatment can potentially prevent fall asthma exacerbations while limiting therapy exposure.
objectiveWe 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.
methodsA 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.
resultsBefore 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.
conclusionsAdding 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.
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Identifiers
What OpenQuestion holds
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.