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Article History

Received: 4 May 2026

Accepted: 16 July 2026

First Online: 27 July 2026

Declarations

Ethics approval and consent to participate: This study involved human participants. A statement within the Methods section to confirm that informed consent was obtained is provided. The study was approved by local ethics committees (lead: University of Luebeck Ethics Committee; reference no. AZ 12–215) and conducted in accordance with the Declaration of Helsinki.

Consent for publication: Not applicable.

Competing interests: LU, LL, JO, KG, FF, MA, VV, CT, AH, NM, LR, IK, LK, SI, HR, FB have nothing to declare. This work was supported by German Center for Lung Research (DZL) (RG, AMD, KR, GH, MK, ME, EvM, TB, CS, BS); German Federal Ministry of Education and Research (BMBF) (AMD, TB, EvM, GH) and RG: Else-Kröner Fresenius Stiftung; AMD: Vertex Pharmaceutical Inc., German Science Foundation, GSK, Oxford University, Novartis, Hogrefe Publishing Company, Department for Pediatric Psychology, Philipps University Marburg, Vertex Pharmaceuticals, StreamedUP, Christiane-Herzog-Foundation, Austrian Society for Rare Disease, Paul-Ehrlich-Institute, German CF Patient Advocacy Board, German CF Clinical Trial Network Executive Committee, ECFS CTN Executive Committee; MW: DFG, HORIZON-MSCA-2023, COVID-19 Research Initiative Schleswig–Holstein, Follow-Up of Respiratory Infections in Schleswig–Holstein (FRISH), intramural funding of the Christian-Albrechts-University Kiel, the University of Lübeck, and the Leibniz Lung Center, Research Center Borstel; SvKR: Wilsing Stiftung Köln; KR: AstraZeneca, Boehringer Ingelheim, Chiesie, Sanofi & Regeneron, Astra Zeneca, Chiesi Pharmaceuticals, CSL Behring, GlaxoSmithKline, Berlin Chemie, Menarini, German Chest Society (DGP), American Thoracic Society (ATS); GH: Sanofi GmbH, MedUpdate, Abbvie; MK: University of Bern, Allergopharma GmbH, Sanofi Aventis GmbH, Infectopharm GmbH, Gesellschaft Pädiatrische Pneumologie e.V; EvM: Bavarian State Ministry of Health and Care for “URS Study”, Go Bio Initial Grant, BMBF (Federal Ministry of Education and Research), European Research Council Award, “BEAR Study”, O.M. Pharma S.A.; Elsevier GmbH, Georg Thieme Verlag, Springer-Verlag GmbH, Elsevier Ltd., Springer Nature Group, Deutscher Apotheker Verlag; Chinese University of Hongkong, European Commission, AstraZeneca, Imperial College London, OM Pharma S.A., Clarivate; ALK-Abello Arzneimittel GmbH, Japanese Society of Pediatric Allergy and Clinical Immunology (JSPACI), Klinikum Rechts der Isar, University of Colorado, Paul-Martini-Stiftung, Astra Zeneca BioPharmaceuticals Medical, Imperial College London, Children´s Hospital Research, Institute of Manitoba Kompetenzzentrum für Ernährung (Kern), OM Pharma S.A., Swedish Pediatric Society for Allergy and Lung Medicine, Chinese College of Allergy and Asthma (CCAA), Abbott Laboratories, Deutscher Apotheker Verlag GmbH & Co. KG, Socieded Chilena de Enfermedades Respiratorias, Japanese Society of Allergology, British Society for Asthma and Clinical Immunology, American Academy of Allergy, Asthma & Immunology, European Respiratory Society (ERS), Ludwig Maximilians University Munich, French Health Research Programs’ Agency, CONSORZIO FUTURO IN RICERCA, Technical University of Munich (TUM); Deutsches Zentrum für Lungenforschung (DZL), Fabio Luigi Massimo Ricciardolo/Contatto S.r.l., Fraunhofer ITEM Hannover, MCCA Institut für Immunologie Uni Wien, Karl-Landsteiner Privatuniversität f. Gesundheitswissenschaften, Swiss Institute of Allergy and Asthma Research (SIAF) Davos (Associated Institute of the University of Zurich) MHH (Medizinische Hochschule Hannover), Natasha Allergy Research Foundation, Deutsche Forschungsgemeinschaft, Gordon Research Conferences, Socieded Chilena de Enfermedades Respiratorias, Arla, Universität Leiden, OM Pharma S.A., American Academy of Allergy, Asthma & Clinical Immunology, Deutsche Forschungsgemeinschaft (DFG), European Respiratory Society (ERS), Deutsche Gesellschaft für Kinder- und Jugendmedizin, World Allergy Organization (WAO), European Parliament, Gesellschaft für Pädiatrische Pneumologie (GPP), European Academy of Allergy and Clinical Immunology (EAACI), Helmholtz Association of German Research Centres, Nobel Conference Stockholm, AAA Congress Sarajevo, Karolinska Institutet, Balzan Foundation, Fondazione Menarini, International Union of Immunological Societies (IUIS), Deutsche Gesellschaft für Allergologie und klinische Immunologie (DGAKI), Collegium Internationale Allergologicum, European Academy of Allergy & Clinical Immunology (EAACI); EvM has patent No. PCT/EP2019/085016 (Barn dust extract for the prevention and treatment of diseases) issued EU, pending US, Royalties paid to ProtectImmun for patent EP2361632 (Specific environmental bacteria for the protection from and/or the treatment of allergic, chronic inflammatory and/or autoimmune disorders, granted on 19 March 2014), and patents EP1411977 (Composition containing bacterial antigens used for the prophylaxis and the treatment of allergic diseases, granted on 18 April 2007), EP1637147 (Stable dust extract for allergy protection, granted on 10 December 2008), and EP 1964570 (Pharmaceutical compound to protect against allergies and inflammatory diseases, granted on 21 November 2012) licensed to ProtectImmun. Patent EP21189353.2. 2021. von Mutius E, Rankl B, Bracher F, Müller C, Walker A, Hauck SM, Merl-Pham J, inventors; PROTEINS IDENTIFIED FROM BARN DUST EXTRACT FOR THE PREVENTION AND TREATMENT OF DISEASES. Patent PCT/US2021/016918. 2021. Martinez FD, Vercelli D, Snyder SA, von Mutius E, Pivniouk V, Marques dos Santos M, inventors; THERAPEUTIC FRACTIONS AND PROTEINS FROM ASTHMA-PROTECTIVE FARM DUST. Patent EP21189353.2. 2021. von Mutius E, Rankl B, Bracher F, Müller C, Walker A, Hauck SM, Merl-Pham J, Adler H, Yildirim A.Ö., Sattler M, Santos Dias Mourao A, Borggräfe J, O´Connor P.D., Plettenburg O, inventors; PROTEINS IDENTIFIED FROM BARN DUST EXTRACT FOR THE PREVENTION AND TREATMENT OF DISEASES. Member of the BEAMS External Scientific Advisory Board (ESAB), Member of the Editorial Board of “The Journal of Allergy and Clinical Immunology: In Practice”, Member of the Scientific Advisory Board of the Children’s Respiratory and Environmental Workgroup (CREW), Member of the International Scientific & Societal Advisory Board (ISSAB) of Utrecht Life Sciences (ULS) University of Utrecht, Member of External Review Panel of the Faculty of Veterinary Science, University of Utrecht, Member of the Selection Committee for the Gottfried Wilhelm Leibniz Programme (DFG), Member of the International Advisory Board of “The Lancet Respiratory Medicine”, Member of the Scientific Advisory Board of the CHILD (Canadian Healthy Infant Longitudinal Development) study, McMaster University, Hamilton, Canada, Member of the Pediatric Scientific Advisory Board Iceland, Member of the Abbott Allergy Risk Reduction Advisory Board, Member of the HpVac Scientific Advisory Board, Member of the OM Pharma Scientific Advisory Board, Member of the Award Committee of the International Balzan Foundation, Member of the Scientific Advisory Board for French Prevention National Research Programme, Member of the Scientific Advisory Panel for The Natasha Allergy Research Foundation; TB: Network University Medicine (NUM), Thieme, HealthHero, PneumoLounge, Pohl Boskamp, Pfizer, Chiesi, AstraZeneca, PohlBoskamp, German Society for Pneumology (DGP); ME: Latvian Council of Science, Travel Grant by the International Milk Genomics Consortium 2023 and by Dutch Longfunds 2025; CS: Consultancy and research funding, Bencard Allergie; Consultancy, Novartis Pharma GmbH; BS: GlaxoSmithKline, Novartis, Sanofi, Astra Zeneca, DGAKI.