Trial reportDrugs2023
Omalizumab in Severe Asthma: Effect on Oral Corticosteroid Exposure and Remodeling. A Randomized Open-Label Parallel Study.
Trial report in Drugs, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- The clinical and pathological histology efficacy of biological therapy for severe asthma with a phenotype of type 2 inflammation - systematic review.Frontiers in immunology · 2025Pooled it
- The efficacy and safety of omalizumab in the treatment of asthma: an overview of systematic reviews and meta analyses.Frontiers in medicine · 2025Pooled it
- Different Inflammatory Phenotypes and Immune Endotypes Drive Disease Heterogeneity in Asthma and COPD.Clinical reviews in allergy & immunology · 2026Review
- Review
- Clinical and Biological Features of a Thickened Basement Membrane Zone in Asthma.American journal of respiratory and critical care medicine · 2025Article
- Evaluation of Long-Term Response to Biological Therapy in Severe Asthma and Considerations for Treatment Adjustment.Journal of clinical medicine · 2025Article
- Review
- Eosinophil-Driven vs. Eosinophil-Associated Severe Asthma: Practical Implications for Target Treatment.International journal of molecular sciences · 2025Review
- Comparative Analysis of ICS Combined with LABA versus Addition of Omalizumab on Transcriptomic Expression Profiles in Patients with Allergic Asthma.Journal of asthma and allergy · 2025Article
- Drugs Used in the Treatment of Viral Infections for the Prevention of Airway Remodeling in Asthma.Mediators of inflammation · 2025Review
- Asthma Biologics: Lung Function, Steroid-Dependence, and Exacerbations.Immunology and allergy clinics of North America · 2024Review
- Mepolizumab in Severe Pediatric Asthma: Certainties and Doubts through a Single-Center Experience and Review of the Literature.Children (Basel, Switzerland) · 2024Article
- The Incredible Adventure of Omalizumab.International journal of molecular sciences · 2024Review
- Article
- [Consensus document for Severe Asthma. 2025 Update].Open respiratory archivesArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 1 country.
Funding
Abstract
introductionData on the clinical efficacy and remodeling of omalizumab therapy in patients on oral corticosteroids (OC) are limited.
objectiveThe purpose of the study is to show that in patients with corticosteroid-dependent asthma, omalizumab is a corticosteroid-sparing therapy able to inhibit airway remodeling and to reduce disease burden (lung function impairment, exacerbations).
methodsThis study is a randomised open-label study evaluating the addition of omalizumab to the standard of care in patients with severe asthma receiving oral corticosteroids. The primary endpoint was represented by the change in OC monthly dose by the end of treatment and secondary endpoints included spirometry changes, airway inflammation (FeNO), number of exacerbations and airways remodelling assessed by bronchial biopsies studied by transmission electron microscopy. As a safety variable, adverse effects were recorded.
resultsEfficacy was assessed for 16 patients in the omalizumab group and 13 in the control group. The final cumulative mean monthly OC doses were 34.7 mg and 217 mg for the omalizumab and control group, respectively; the mean difference between groups adjusted for baseline was -148.1 [95% confidence interval (CI) -243.6, -52.5; p = 0.004]. OC withdrawal of 75% versus 7.7% (p = 0.001) was observed in the omalizumab and control group, respectively. Omalizumab provided a slowing of forced expiratory volume in one second (FEV
conclusionsOmalizumab showed a marked OC-sparing capacity and was associated with an improvement in clinical management that correlated with bronchial epithelial repair. In OC-dependent asthma, reversibility of remodelling is possible; the concepts that basement membrane enlargement is detrimental and that chronic airway obstruction is systematically irreversible are outdated (EudraCT: 2009-010914-31).
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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.