Cargando…
Bacterial lysate add‐on therapy to reduce exacerbations in severe asthma: A double‐blind placebo‐controlled trial
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 p...
Autores principales: | , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9292626/ https://www.ncbi.nlm.nih.gov/pubmed/34289183 http://dx.doi.org/10.1111/cea.13990 |
_version_ | 1784749415787921408 |
---|---|
author | de Boer, Geertje M. Braunstahl, Gert‐Jan van der Ploeg, Esmee K. van Zelst, Cathelijne M. van Bruggen, Alie Epping, Guido van Nimwegen, Menno Verhoeven, Gert Birnie, Erwin Boxma‐de Klerk, Bianca M. de Bruijn, Marjolein J. W. Stadhouders, Ralph Hendriks, Rudi W. Tramper‐Stranders, Gerdien A. |
author_facet | de Boer, Geertje M. Braunstahl, Gert‐Jan van der Ploeg, Esmee K. van Zelst, Cathelijne M. van Bruggen, Alie Epping, Guido van Nimwegen, Menno Verhoeven, Gert Birnie, Erwin Boxma‐de Klerk, Bianca M. de Bruijn, Marjolein J. W. Stadhouders, Ralph Hendriks, Rudi W. Tramper‐Stranders, Gerdien A. |
author_sort | de Boer, Geertje M. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9292626 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-92926262022-07-20 Bacterial lysate add‐on therapy to reduce exacerbations in severe asthma: A double‐blind placebo‐controlled trial de Boer, Geertje M. Braunstahl, Gert‐Jan van der Ploeg, Esmee K. van Zelst, Cathelijne M. van Bruggen, Alie Epping, Guido van Nimwegen, Menno Verhoeven, Gert Birnie, Erwin Boxma‐de Klerk, Bianca M. de Bruijn, Marjolein J. W. Stadhouders, Ralph Hendriks, Rudi W. Tramper‐Stranders, Gerdien A. Clin Exp Allergy Clinical Trial 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. John Wiley and Sons Inc. 2021-08-06 2021-09 /pmc/articles/PMC9292626/ /pubmed/34289183 http://dx.doi.org/10.1111/cea.13990 Text en © 2021 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Clinical Trial de Boer, Geertje M. Braunstahl, Gert‐Jan van der Ploeg, Esmee K. van Zelst, Cathelijne M. van Bruggen, Alie Epping, Guido van Nimwegen, Menno Verhoeven, Gert Birnie, Erwin Boxma‐de Klerk, Bianca M. de Bruijn, Marjolein J. W. Stadhouders, Ralph Hendriks, Rudi W. Tramper‐Stranders, Gerdien A. Bacterial lysate add‐on therapy to reduce exacerbations in severe asthma: A double‐blind placebo‐controlled trial |
title | Bacterial lysate add‐on therapy to reduce exacerbations in severe asthma: A double‐blind placebo‐controlled trial |
title_full | Bacterial lysate add‐on therapy to reduce exacerbations in severe asthma: A double‐blind placebo‐controlled trial |
title_fullStr | Bacterial lysate add‐on therapy to reduce exacerbations in severe asthma: A double‐blind placebo‐controlled trial |
title_full_unstemmed | Bacterial lysate add‐on therapy to reduce exacerbations in severe asthma: A double‐blind placebo‐controlled trial |
title_short | Bacterial lysate add‐on therapy to reduce exacerbations in severe asthma: A double‐blind placebo‐controlled trial |
title_sort | bacterial lysate add‐on therapy to reduce exacerbations in severe asthma: a double‐blind placebo‐controlled trial |
topic | Clinical Trial |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9292626/ https://www.ncbi.nlm.nih.gov/pubmed/34289183 http://dx.doi.org/10.1111/cea.13990 |
work_keys_str_mv | AT deboergeertjem bacteriallysateaddontherapytoreduceexacerbationsinsevereasthmaadoubleblindplacebocontrolledtrial AT braunstahlgertjan bacteriallysateaddontherapytoreduceexacerbationsinsevereasthmaadoubleblindplacebocontrolledtrial AT vanderploegesmeek bacteriallysateaddontherapytoreduceexacerbationsinsevereasthmaadoubleblindplacebocontrolledtrial AT vanzelstcathelijnem bacteriallysateaddontherapytoreduceexacerbationsinsevereasthmaadoubleblindplacebocontrolledtrial AT vanbruggenalie bacteriallysateaddontherapytoreduceexacerbationsinsevereasthmaadoubleblindplacebocontrolledtrial AT eppingguido bacteriallysateaddontherapytoreduceexacerbationsinsevereasthmaadoubleblindplacebocontrolledtrial AT vannimwegenmenno bacteriallysateaddontherapytoreduceexacerbationsinsevereasthmaadoubleblindplacebocontrolledtrial AT verhoevengert bacteriallysateaddontherapytoreduceexacerbationsinsevereasthmaadoubleblindplacebocontrolledtrial AT birnieerwin bacteriallysateaddontherapytoreduceexacerbationsinsevereasthmaadoubleblindplacebocontrolledtrial AT boxmadeklerkbiancam bacteriallysateaddontherapytoreduceexacerbationsinsevereasthmaadoubleblindplacebocontrolledtrial AT debruijnmarjoleinjw bacteriallysateaddontherapytoreduceexacerbationsinsevereasthmaadoubleblindplacebocontrolledtrial AT stadhoudersralph bacteriallysateaddontherapytoreduceexacerbationsinsevereasthmaadoubleblindplacebocontrolledtrial AT hendriksrudiw bacteriallysateaddontherapytoreduceexacerbationsinsevereasthmaadoubleblindplacebocontrolledtrial AT tramperstrandersgerdiena bacteriallysateaddontherapytoreduceexacerbationsinsevereasthmaadoubleblindplacebocontrolledtrial |