Institut for Folkesundhed

TY - JOUR

T1 - Technical standards in allergen exposure chambers worldwide - an EAACI Task Force Report

AU - Pfaar, Oliver

AU - Bergmann, Karl-Christian

AU - Bonini, Sergio

AU - Compalati, Enrico

AU - Domis, Nathalie

AU - de Blay, Frédéric

AU - de Kam, Pieter-Jan

AU - Devillier, Philippe

AU - Durham, Stephen R

AU - Ellis, Anne K

AU - Gherasim, Alina

AU - Haya, Laura

AU - Hohlfeld, Jens M

AU - Horak, Friedrich

AU - Iinuma, Tomohisa

AU - Jacobs, Robert L

AU - Jacobi, Henrik Hugo

AU - Jutel, Marek

AU - Kaul, Susanne

AU - Kelly, Suzanne

AU - Klimek, Ludger

AU - Larché, Mark

AU - Lemell, Patrick

AU - Mahler, Vera

AU - Nolte, Hendrik

AU - Okamoto, Yoshitaka

AU - Patel, Piyush

AU - Rabin, Ronald L

AU - Rather, Cynthia

AU - Sager, Angelika

AU - Salapatek, Anne Marie

AU - Sigsgaard, Torben

AU - Togias, Alkis

AU - Willers, Christoph

AU - Yang, William H

AU - Zieglmayer, René

AU - Zuberbier, Torsten

AU - Zieglmayer, Petra

N1 - © 2021 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

PY - 2021/12

Y1 - 2021/12

N2 - 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.

AB - 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.

KW - COVID-19

KW - allergen exposure chambers

KW - allergen immunotherapy

KW - clinical trials

KW - technical standards

U2 - 10.1111/all.14957

DO - 10.1111/all.14957

M3 - Journal article

C2 - 34028057

VL - 76

SP - 3589

EP - 3612

JO - Allergy: European Journal of Allergy and Clinical Immunology

JF - Allergy: European Journal of Allergy and Clinical Immunology

SN - 0105-4538

IS - 12

ER -