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

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Standard

Technical standards in allergen exposure chambers worldwide - an EAACI Task Force Report. / Pfaar, Oliver; Bergmann, Karl-Christian; Bonini, Sergio; Compalati, Enrico; Domis, Nathalie; de Blay, Frédéric; de Kam, Pieter-Jan; Devillier, Philippe; Durham, Stephen R; Ellis, Anne K; Gherasim, Alina; Haya, Laura; Hohlfeld, Jens M; Horak, Friedrich; Iinuma, Tomohisa; Jacobs, Robert L; Jacobi, Henrik Hugo; Jutel, Marek; Kaul, Susanne; Kelly, Suzanne; Klimek, Ludger; Larché, Mark; Lemell, Patrick; Mahler, Vera; Nolte, Hendrik; Okamoto, Yoshitaka; Patel, Piyush; Rabin, Ronald L; Rather, Cynthia; Sager, Angelika; Salapatek, Anne Marie; Sigsgaard, Torben; Togias, Alkis; Willers, Christoph; Yang, William H; Zieglmayer, René; Zuberbier, Torsten; Zieglmayer, Petra.

I: Allergy: European Journal of Allergy and Clinical Immunology, Bind 76, Nr. 12, 12.2021, s. 3589-3612.

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

Harvard

Pfaar, O, Bergmann, K-C, Bonini, S, Compalati, E, Domis, N, de Blay, F, de Kam, P-J, Devillier, P, Durham, SR, Ellis, AK, Gherasim, A, Haya, L, Hohlfeld, JM, Horak, F, Iinuma, T, Jacobs, RL, Jacobi, HH, Jutel, M, Kaul, S, Kelly, S, Klimek, L, Larché, M, Lemell, P, Mahler, V, Nolte, H, Okamoto, Y, Patel, P, Rabin, RL, Rather, C, Sager, A, Salapatek, AM, Sigsgaard, T, Togias, A, Willers, C, Yang, WH, Zieglmayer, R, Zuberbier, T & Zieglmayer, P 2021, 'Technical standards in allergen exposure chambers worldwide - an EAACI Task Force Report', Allergy: European Journal of Allergy and Clinical Immunology, bind 76, nr. 12, s. 3589-3612. https://doi.org/10.1111/all.14957

APA

Pfaar, O., Bergmann, K-C., Bonini, S., Compalati, E., Domis, N., de Blay, F., de Kam, P-J., Devillier, P., Durham, S. R., Ellis, A. K., Gherasim, A., Haya, L., Hohlfeld, J. M., Horak, F., Iinuma, T., Jacobs, R. L., Jacobi, H. H., Jutel, M., Kaul, S., ... Zieglmayer, P. (2021). Technical standards in allergen exposure chambers worldwide - an EAACI Task Force Report. Allergy: European Journal of Allergy and Clinical Immunology, 76(12), 3589-3612. https://doi.org/10.1111/all.14957

CBE

Pfaar O, Bergmann K-C, Bonini S, Compalati E, Domis N, de Blay F, de Kam P-J, Devillier P, Durham SR, Ellis AK, Gherasim A, Haya L, Hohlfeld JM, Horak F, Iinuma T, Jacobs RL, Jacobi HH, Jutel M, Kaul S, Kelly S, Klimek L, Larché M, Lemell P, Mahler V, Nolte H, Okamoto Y, Patel P, Rabin RL, Rather C, Sager A, Salapatek AM, Sigsgaard T, Togias A, Willers C, Yang WH, Zieglmayer R, Zuberbier T, Zieglmayer P. 2021. Technical standards in allergen exposure chambers worldwide - an EAACI Task Force Report. Allergy: European Journal of Allergy and Clinical Immunology. 76(12):3589-3612. https://doi.org/10.1111/all.14957

MLA

Pfaar, Oliver o.a.. "Technical standards in allergen exposure chambers worldwide - an EAACI Task Force Report". Allergy: European Journal of Allergy and Clinical Immunology. 2021, 76(12). 3589-3612. https://doi.org/10.1111/all.14957

Vancouver

Pfaar O, Bergmann K-C, Bonini S, Compalati E, Domis N, de Blay F o.a. Technical standards in allergen exposure chambers worldwide - an EAACI Task Force Report. Allergy: European Journal of Allergy and Clinical Immunology. 2021 dec.;76(12):3589-3612. https://doi.org/10.1111/all.14957

Author

Pfaar, Oliver ; Bergmann, Karl-Christian ; Bonini, Sergio ; Compalati, Enrico ; Domis, Nathalie ; de Blay, Frédéric ; de Kam, Pieter-Jan ; Devillier, Philippe ; Durham, Stephen R ; Ellis, Anne K ; Gherasim, Alina ; Haya, Laura ; Hohlfeld, Jens M ; Horak, Friedrich ; Iinuma, Tomohisa ; Jacobs, Robert L ; Jacobi, Henrik Hugo ; Jutel, Marek ; Kaul, Susanne ; Kelly, Suzanne ; Klimek, Ludger ; Larché, Mark ; Lemell, Patrick ; Mahler, Vera ; Nolte, Hendrik ; Okamoto, Yoshitaka ; Patel, Piyush ; Rabin, Ronald L ; Rather, Cynthia ; Sager, Angelika ; Salapatek, Anne Marie ; Sigsgaard, Torben ; Togias, Alkis ; Willers, Christoph ; Yang, William H ; Zieglmayer, René ; Zuberbier, Torsten ; Zieglmayer, Petra. / Technical standards in allergen exposure chambers worldwide - an EAACI Task Force Report. I: Allergy: European Journal of Allergy and Clinical Immunology. 2021 ; Bind 76, Nr. 12. s. 3589-3612.

Bibtex

@article{dc5e65fd640e4b61964dc19350582040,
title = "Technical standards in allergen exposure chambers worldwide - an EAACI Task Force Report",
abstract = "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.",
keywords = "COVID-19, allergen exposure chambers, allergen immunotherapy, clinical trials, technical standards",
author = "Oliver Pfaar and Karl-Christian Bergmann and Sergio Bonini and Enrico Compalati and Nathalie Domis and {de Blay}, Fr{\'e}d{\'e}ric and {de Kam}, Pieter-Jan and Philippe Devillier and Durham, {Stephen R} and Ellis, {Anne K} and Alina Gherasim and Laura Haya and Hohlfeld, {Jens M} and Friedrich Horak and Tomohisa Iinuma and Jacobs, {Robert L} and Jacobi, {Henrik Hugo} and Marek Jutel and Susanne Kaul and Suzanne Kelly and Ludger Klimek and Mark Larch{\'e} and Patrick Lemell and Vera Mahler and Hendrik Nolte and Yoshitaka Okamoto and Piyush Patel and Rabin, {Ronald L} and Cynthia Rather and Angelika Sager and Salapatek, {Anne Marie} and Torben Sigsgaard and Alkis Togias and Christoph Willers and Yang, {William H} and Ren{\'e} Zieglmayer and Torsten Zuberbier and Petra Zieglmayer",
note = "{\textcopyright} 2021 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.",
year = "2021",
month = dec,
doi = "10.1111/all.14957",
language = "English",
volume = "76",
pages = "3589--3612",
journal = "Allergy: European Journal of Allergy and Clinical Immunology",
issn = "0105-4538",
publisher = "Wiley Online",
number = "12",

}

RIS

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 -