Scientific Publications by FDA Staff

Allergy 2017 Jul;72(7):1035-42

Allergen Exposure Chambers (AEC): harmonizing current concepts and projecting the needs for the future--an EAACI position paper.

Pfaar O, Calderon MA, Andrews CP, Angjeli E, Bergmann KC, Bonlokke JH, de Blay F, Devillier P, Ellis AK, Gerth van Wijk R, Hohlfeld J, Horak F, Jutel M, Jacobs RL, Jacobsen L, Kaul S, Larche M, Larenas-Linnemann D, Mosges R, Nolte H, Patel P, Peoples L, Rabin RL, Rather C, Salapatek AM, Sigsgaard T, Thaarup S, Yang J, Zieglmayer P, Zuberbier T, Demoly P

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.