Bacterial lysate add-on therapy to reduce exacerbations in severe asthma: A double-blind placebo-controlled trial.

Autor:	de Boer GM; Department of Pulmonary Medicine, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.; Department of Pulmonary Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands., Braunstahl GJ; Department of Pulmonary Medicine, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.; Department of Pulmonary Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands., van der Ploeg EK; Department of Pulmonary Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands.; Department of Cell Biology, Erasmus University Medical Center, Rotterdam, The Netherlands., van Zelst CM; Department of Pulmonary Medicine, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.; Department of Pulmonary Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands., van Bruggen A; Department of Pulmonary Medicine, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands., Epping G; Department of Pulmonary Medicine, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands., van Nimwegen M; Department of Pulmonary Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands., Verhoeven G; Department of Pulmonary Medicine, Maasstad hospital, Rotterdam, The Netherlands., Birnie E; Department of Scientific Education, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands., Boxma-de Klerk BM; Department of Scientific Education, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands., de Bruijn MJW; Department of Pulmonary Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands., Stadhouders R; Department of Pulmonary Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands.; Department of Cell Biology, Erasmus University Medical Center, Rotterdam, The Netherlands., Hendriks RW; Department of Pulmonary Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands., Tramper-Stranders GA; Department of Pulmonary Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands.; Department of Pediatrics, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.
Jazyk:	angličtina
Zdroj:	Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology [Clin Exp Allergy] 2021 Sep; Vol. 51 (9), pp. 1172-1184. Date of Electronic Publication: 2021 Aug 06.
DOI:	10.1111/cea.13990
Abstrakt:	Background: Asthma 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. Aims: To 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. Methods: Asthma 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. Results: Seventy-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. Conclusion: Although 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. (© 2021 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd.)
Databáze:	MEDLINE
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