Torben Sigsgaard

Allergen Exposure Chambers: harmonizing current concepts and projecting the needs for the future - an EAACI Position Paper

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

DOI

  • O Pfaar, Department of Otorhinolaryngology, Head and Neck Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany., Tyskland
  • M A Calderon, Section of Allergy and Clinical Immunology, Imperial College London, London, United Kingdom., Storbritannien
  • C P Andrews, Biogenics Research Chamber LLC, San Antonio, Texas, USA., USA
  • E Angjeli, Ora, Inc, Andover, Massachusetts, USA., USA
  • K C Bergmann, Allergy-Center Charité, Charité University Hospital, Berlin, Germany., Tyskland
  • J H Bønløkke
  • F de Blay, ALYATEC, Chest Disease Department, University Hospital of Strasbourg, Strasbourg University, Strasbourg, France., Frankrig
  • P Devillier, UPRES EA 220, Airway Diseases Department, Hôpital Foch, Université Versailles Saint Quentin, University Paris Saclay, Suresnes, France., Frankrig
  • A K Ellis, Department of Medicine, Queen's University, Kingston, Ontario, Canada., Canada
  • R Gerth van Wijk, Section of Allergology, Department of Internal Medicine, Erasmus MC, Rotterdam, The Netherlands., Holland
  • J Hohlfeld, Department of Clinical Airway Research, Fraunhofer Institute of Toxicology and Experimental Medicine (ITEM), Hannover, Germany., Tyskland
  • F Horak, Vienna Challenge Chamber, Vienna, Austria., Østrig
  • M Jutel, Wroclaw Medical University, Wrocław, Poland., Polen
  • R L Jacobs, Biogenics Research Chamber LLC, San Antonio, Texas, USA., USA
  • L Jacobsen, ALC, Allergy Learning and Consulting, Copenhagen, Denmark.
  • ,
  • S Kaul, Division of Allergology, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany., Tyskland
  • M Larché, Firestone Institute for Respiratory Health, Department of Medicine, St. Joseph's Hospital Healthcare, McMaster University, Hamilton, Canada., Canada
  • D Larenas-Linnemann, Pediatric Allergy and Asthma Clinic, Department of Investigation, Hospital Médica Sur, México City, México., Mexico
  • R Mösges, Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), University Hospital of Cologne, University at Cologne, Cologne, Germany., Tyskland
  • H Nolte, Merck&Co, Kenilworth, New Jersey, USA., USA
  • P Patel, Inflamax Research Inc, Mississauga, Ontario, Canada.
  • ,
  • L Peoples, Ora, Inc, Andover, Massachusetts, USA., USA
  • R L Rabin, Laboratories of Clinical Investigation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, US., USA
  • C Rather, Biogenics Research Chamber LLC, San Antonio, Texas, USA., USA
  • A M Salapatek, Inflamax Research Inc, Mississauga, Ontario, Canada., Canada
  • T Sigsgaard
  • S Thaarup, Mobile Chamber Experts GmbH (MCX), Berlin, Germany., Tyskland
  • J Yang, Red Maple Trials, Ottawa, Ontario, Canada., Canada
  • P Zieglmayer, Vienna Challenge Chamber, Vienna, Austria., Østrig
  • T Zuberbier, Secretary General of the Global Allergy and Asthma European Network (GA2LEN), Department of Dermatology & Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany., Tyskland
  • P Demoly, Département de Pneumologie et Addictologie, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier, Montpellier, France., Frankrig

BACKGOUND: Allergen exposure chambers (AEC) are clinical facilities allowing for controlled exposure of subjects to allergens in an enclosed environment. AEC 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 multi-centre field trials for evaluation of novel therapeutics. To date, AEC studies conducted have been monocentric and have followed protocols unique to each center. Because there are technical differences among AEC, it may be necessary to define parameters to standardize the AEC 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 inter-chamber variability and reproducibility, in addition to comparability with field trials and specifics of paediatric trials and regulatory issues.

CONCLUSION: This EAACI Position Paper aims to harmonize current concepts in AEC 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. This article is protected by copyright. All rights reserved.

OriginalsprogEngelsk
TidsskriftAllergy: European Journal of Allergy and Clinical Immunology
Vol/bind72
Nummer7
Sider (fra-til)1035-1042
Antal sider8
ISSN0105-4538
DOI
StatusUdgivet - jul. 2017

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