Technical standards in allergen exposure chambers worldwide - an EAACI Task Force Report

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  • Oliver Pfaar, Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany., Tyskland
  • Karl-Christian Bergmann, Charité – Universitätsmedizin Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Institute of Health and Nursing Science, Berlin, Germany , Tyskland
  • Sergio Bonini, National Institute for Translational Medicine, Italien
  • Enrico Compalati, Medical Department, Lofarma S.p.A, Milan, Italien
  • Nathalie Domis, ALYATEC Environmental Exposure Chamber, Frankrig
  • Frédéric de Blay, ALYATEC Environmental Exposure Chamber, Chest Diseases Department, Strasbourg University Hospital, Strasbourg, France, Frankrig
  • Pieter-Jan de Kam, Allergy Therapeutics Ltd, Storbritannien
  • Philippe Devillier, University Paris-Saclay, University Paris-Sud, Villejuif, Frankrig
  • Stephen R Durham, Imperial Coll London, Imperial College London, UKDRI, Storbritannien
  • Anne K Ellis, Departments of Medicine and Biomedical & Molecular Sciences, Queen's University, Kingston, Allergy Research Unit, Kingston General Health Research Institute, Kingston, Canada
  • Alina Gherasim, ALYATEC Environmental Exposure Chamber, Frankrig
  • Laura Haya, Red Maple Trials Inc, Canada
  • Jens M Hohlfeld, Fraunhofer Institute for Toxicology and Experimental Medicine and Department of Respiratory Medicine, Tyskland
  • Friedrich Horak, Allergy Center Vienna West, Østrig
  • Tomohisa Iinuma, Chiba University and Chiba Rosai Hospital, Japan
  • Robert L Jacobs, Biogenics Research Institute, USA
  • Henrik Hugo Jacobi, Bioneer A/S, Hørsholm, Kogle Allé 2, 2970, Hørsholm, Denmark., Danmark
  • Marek Jutel, Wroclaw Medical University, University of Lower Silesia, Wroclaw, Poland., All-MED Medical Research Institute, Wrocław, Polen
  • Susanne Kaul, Paul-Ehrlich-Institut, Tyskland
  • Suzanne Kelly, Red Maple Trials Inc, Canada
  • Ludger Klimek, Center for Rhinology and Allergology, Allergy Center Rhineland-Palatinate, Mainz University Medical Center, Mainz, Tyskland
  • Mark Larché, Divisions of Clinical Immunology & Allergy, and Respirology, Department of Medicine and Firestone Institute for Respiratory Health, McMaster University, Hamilton, ON, Canada
  • Patrick Lemell, Vienna Challenge Chamber, Vienna, Austria., Østrig
  • Vera Mahler, Paul-Ehrlich-Institut, Tyskland
  • Hendrik Nolte, Bioneer A/S, Hørsholm, Kogle Allé 2, 2970, Hørsholm, Denmark., Danmark
  • Yoshitaka Okamoto, Chiba University and Chiba Rosai Hospital, Japan
  • Piyush Patel, Cliantha Research Limited, Providence Therapeutics, Canada
  • Ronald L Rabin, Center for Biologics Evaluation and Research, USA
  • Cynthia Rather, Biogenics Research Institute, USA
  • Angelika Sager, LETI Pharma, Tyskland
  • Anne Marie Salapatek, Cliantha Research Limited, Canada
  • Torben Sigsgaard
  • Alkis Togias, National Institute of Allergy and Infectious Diseases, USA
  • Christoph Willers, Allergopharma GmbH & Co KG, Tyskland
  • William H Yang, Red Maple Trials Inc, Canada
  • René Zieglmayer, Vienna Challenge Chamber, Vienna, Austria., Østrig
  • Torsten Zuberbier, Charité – Universitätsmedizin Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Institute of Health and Nursing Science, Berlin, Germany , Tyskland
  • Petra Zieglmayer, Vienna Challenge Chamber, Vienna, Austria., Karl-Landsteiner University of Health Sciences, Østrig

Allergen exposure chambers (AECs) can be used for controlled exposure to allergenic and non-allergenic airborne particles in an enclosed environment, in order to (i) characterize the pathological features of respiratory diseases and (ii) contribute to and accelerate the clinical development of pharmacological treatments and allergen immunotherapy for allergic disease of the respiratory tract (such as allergic rhinitis, allergic rhinoconjunctivitis, and allergic asthma). In the guidelines of the European Medicines Agency for the clinical development of products for allergen immunotherapy (AIT), the role of AECs in determining primary endpoints in dose-finding Phase II trials is emphasized. Although methodologically insulated from the variability of natural pollen exposure, chamber models remain confined to supporting secondary, rather than primary, endpoints in Phase III registration trials. The need for further validation in comparison with field exposure is clearly mandated. On this basis, the European Academy of Allergy and Clinical Immunology (EAACI) initiated a Task Force in 2015 charged to gain a better understanding of how AECs can generate knowledge about respiratory allergies and can contribute to the clinical development of treatments. Researchers working with AECs worldwide were asked to provide technical information in eight sections: (i) dimensions and structure of the AEC, (ii) AEC staff, (iii) airflow, air processing, and operating conditions, (iv) particle dispersal, (v) pollen/particle counting, (vi) safety and non-contamination measures, (vii) procedures for symptom assessments, (viii) tested allergens/substances and validation procedures. On this basis, a minimal set of technical requirements for AECs applied to the field of allergology is proposed.

OriginalsprogEngelsk
TidsskriftAllergy: European Journal of Allergy and Clinical Immunology
Vol/bind76
Nummer12
Sider (fra-til)3589-3612
Antal sider24
ISSN0105-4538
DOI
StatusUdgivet - dec. 2021

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© 2021 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

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