title: Allergen exposure chambers: harmonizing current concepts and projecting the needs for the future - an EAACI Position Paper.
abstract: BACKGROUND
  Allergen exposure chambers (AECs) are clinical facilities allowing for controlled exposure of subjects to allergens in an enclosed environment. AECs have contributed towards characterizing the pathophysiology of respiratory allergic diseases and the pharmacological properties of new therapies. In addition, they are complementary to and offer some advantages over traditional multicentre field trials for evaluation of novel therapeutics. To date, AEC studies conducted have been monocentric and have followed protocols unique to each centre. Because there are technical differences among AECs, it may be necessary to define parameters to standardize the AECs so that studies may be extrapolated for driving basic immunological research and for marketing authorization purposes by regulatory authorities.
  
  
  METHODS
  For this task force initiative of the European Academy of Allergy and Clinical Immunology (EAACI), experts from academia and regulatory agencies met with chamber operators to list technical, clinical and regulatory unmet needs as well as the prerequisites for clinical validation.
  
  
  RESULTS
  The latter covered the validation process, standardization of challenges and outcomes, intra- and interchamber variability and reproducibility, in addition to comparability with field trials and specifics of paediatric trials and regulatory issues.
  
  
  CONCLUSIONS
  This EAACI Position Paper aims to harmonize current concepts in AECs and to project unmet needs with the intent to enhance progress towards use of these facilities in determining safety and efficacy of new therapeutics in the future.
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authors.identifier: http://orcid.org/0000-0003-4374-9639
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authors.affiliation: Section of Allergy and Clinical Immunology, Imperial College London, London, UK.|National Heart & Lung Institute, Royal Brompton Hospital, London, UK.
authors.forename: M A
authors.initials: MA
authors.lastname: Calderon
authors.affiliation: Biogenics Research Chamber LLC, San Antonio, TX, USA.
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authors.affiliation: Allergy-Centre-Charité, Charité Universitätsmedizin Berlin, Berlin, Germany.
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authors.affiliation: Department of Public Health, Section for Environment, Occupation and Health, Danish Ramazzini Center, Aarhus University, Aarhus, Denmark.
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authors.identifier: http://orcid.org/0000-0002-8247-6576
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authors.affiliation: ALYATEC, Strasbourg, France.|Chest Disease Department, University Hospital of Strasbourg and Federation of Translational Medicine, EA3072, Strasbourg University, Strasbourg, France.
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authors.initials: F
authors.lastname: de Blay
authors.affiliation: UPRES EA 220, Airway Diseases Department, Hôpital Foch, Université Versailles Saint Quentin, University Paris Saclay, Suresnes, France.
authors.forename: P
authors.identifier: http://orcid.org/0000-0001-6054-1886
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authors.lastname: Devillier
authors.affiliation: Department of Medicine, Queen's University, Kingston, ON, Canada.|Environmental Exposure Unit, Kingston General Hospital, Kingston, ON, Canada.
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authors.identifier: http://orcid.org/0000-0002-0725-2353
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authors.affiliation: Section of Allergology, Department of Internal Medicine, Erasmus MC, Rotterdam, The Netherlands.
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authors.affiliation: Department of Clinical Airway Research, Fraunhofer Institute of Toxicology and Experimental Medicine (ITEM), Hannover, Germany, Member of the German Center for Lung Research.
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authors.identifier: http://orcid.org/0000-0003-2646-6186
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authors.affiliation: Biogenics Research Chamber LLC, San Antonio, TX, USA.
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authors.affiliation: ALL-MED Medical Research Institute, Wrocław, Poland.|Wroclaw Medical University, Wrocław, Poland.
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authors.affiliation: Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), University Hospital of Cologne, University at Cologne, Cologne, Germany.
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authors.identifier: http://orcid.org/0000-0002-1928-810X
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authors.identifier: http://orcid.org/0000-0003-3496-0504
authors.initials: RL
authors.lastname: Rabin
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authors.lastname: Rather
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authors.initials: AM
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authors.affiliation: Department of Public Health, Section for Environment, Occupation and Health, Danish Ramazzini Center, Aarhus University, Aarhus, Denmark.
authors.forename: T
authors.initials: T
authors.lastname: Sigsgaard
authors.affiliation: Mobile Chamber Experts GmbH (MCX), Berlin, Germany.
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authors.lastname: Thaarup
authors.affiliation: Red Maple Trials, Ottawa, ON, Canada.
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authors.lastname: Yang
authors.affiliation: Vienna Challenge Chamber, Vienna, Austria.
authors.forename: P
authors.identifier: http://orcid.org/0000-0001-5432-9459
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authors.lastname: Zieglmayer
authors.affiliation: Global Allergy and Asthma European Network (GA2LEN), Department of Dermatology & Allergy, Charité Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: T
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authors.lastname: Zuberbier
authors.affiliation: Département de Pneumologie et Addictologie, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier, Montpellier, France.|UPMC Paris 06, UMR-S 1136, IPLESP, Equipe EPAR, Sorbonne Universités, Paris, France.
authors.forename: P
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authors.lastname: Demoly
mesh_terms: D000485:Allergens / Q000276:immunology*; D003888:Desensitization, Immunologic / Q000379:methods* / Q000592:standards / Q000639:trends; D004780:Environment, Controlled; D006291:Health Policy; D006801:Humans; D006967:Hypersensitivity / Q000276:immunology / Q000628:therapy; D019570:Inhalation Exposure / Q000009:adverse effects; D015203:Reproducibility of Results
chemical_list: D000485:Allergens
keywords: allergen exposure chambers; allergic; clinical trials; rhinitis; validation