Trial reportClinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology2021
Bacterial lysate add-on therapy to reduce exacerbations in severe asthma: A double-blind placebo-controlled trial.
Trial report in Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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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.
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Who cites it
13 citing papers in PubMed, 22 citations in OpenAlex.
- Bacterial Lysates Add-On Therapy to Reduce Postoperative Recurrence in Nasal Polyps.The Laryngoscope · 2026Trial
- Decentralized example of a randomized clinical trial: OM-85 use in older patients at risk of respiratory tract infections.Aging clinical and experimental research · 2026Trial
- Bacterial lysate add-on therapy to reduce exacerbations in severe asthma: A double-blind placebo-controlled trial.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2021Trial
- Mechanisms and therapeutic strategies of asthma: from bench to bedside.Signal transduction and targeted therapy · 2026Review
- The impact of bacterial lysate (OM-85) on clinical and immunological parameters in children with allergic rhinitis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025Article
- Efficacy of OM-85 (Broncho-Vaxom) for prevention of acute exacerbations in patients with chronic airway diseases or chronic bronchitis: a systematic review and meta-analysis.Journal of thoracic disease · 2025Article
- European Respiratory Society Research Seminar on Preventing Pediatric Asthma.Pediatric pulmonology · 2025Review
- The Role of Postbiotics in Asthma Treatment.Microorganisms · 2024Review
- Clinical Remission in Patients Affected by Severe Eosinophilic Asthma on Dupilumab Therapy: A Long-Term Real-Life Study.Journal of clinical medicine · 2024Article
- Oral Bacterial Lysate OM-85: Advances in Pharmacology and Therapeutics.Drug design, development and therapy · 2024Review
- The preprogrammed anti-inflammatory phenotypes of CD11cJournal of translational medicine · 2023Article
- Bacterial lysate add-on therapy in adult and childhood asthma: a systematic review and meta-analysis.Journal of thoracic disease · 2023Article
- Effectiveness of polyvalent bacterial lysate for pediatric asthma control: a retrospective propensity score-matched cohort study.Translational pediatrics · 2022Article
Corrections and comments
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Authors and funding
14 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundAsthma exacerbations are frequently induced by respiratory tract infections (RTIs). Bacterial lysates have been described to possess immune-modulatory effects and reduce RTIs as well as asthma symptoms in children. However, whether bacterial lysates have similar effects in adult asthma patients is unknown.
aimsTo reduce asthma exacerbations by add-on bacterial lysate therapy in adults with severe asthma and to characterize the clinical and immune-modulatory effects of this treatment.
methodsAsthma patients (GINA 4) with ≥2 annual exacerbations in the previous year were included. The intervention regimen consisted of OM-85/placebo for 10 consecutive days per month for 6 months during two winter seasons. Primary end-point was the number of severe asthma exacerbations within 18 months. The study was approved by the national and local ethical review board and registered in the Dutch Trial Registry (NL5752). All participants provided written informed consent.
resultsSeventy-five participants were included (38 OM-85; 37 placebo). Exacerbation frequencies were not different between the groups after 18 months (incidence rate ratio 1.07, 95%CI [0.68-1.69], p = 0.77). With the use of OM-85, FEV1% increased by 3.81% (p = 0.04) compared with placebo. Nasopharyngeal swabs taken during RTIs detected a virus less frequently in patients using OM-85 compared to placebo (30.5% vs. 48.0%, p = 0.02). In subjects with type 2 inflammation adherent to the protocol (22 OM-85; 20 placebo), a non-statistically significant decrease in exacerbations in the OM-85 group was observed (IRR = 0.71, 95%CI [0.39-1.26], p = 0.25). Immune-modulatory effects included an increase in several plasma cytokines in the OM-85 group, especially IL-10 and interferons. Peripheral blood T- and B cell subtyping, including regulatory T cells, did not show differences between the groups.
conclusionAlthough OM-85 may have immune-modulatory effects, it did not reduce asthma exacerbations in this heterogeneous severe adult asthma group. Post hoc analysis showed a potential clinical benefit in patients with type 2 inflammation.
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