Universität zu Köln

Pfaar, O., Calderon, M. A., Andrews, C. P., Angjeli, E., Bergmann, K. C., Bonlokke, J. H., de Blay, F., Devillier, P., Ellis, A. K., van Wijk, R. Gerth, Hohlfeld, J. M., Horak, F., Jacobs, R. L., Jacobsen, L., Jutel, M., Kaul, S., Larche, M., Larenas-Linnemann, D., Moesges, R., Nolte, H., Patel, P., Peoples, L., Rabin, R. L., Rather, C., Salapatek, A. M., Sigsgaard, T., Thaarup, S., Yang, J., Zieglmayer, P., Zuberbier, T. and Demoly, P. (2017). Allergen exposure chambers: harmonizing current concepts and projecting the needs for the future - an EAACI Position Paper. Allergy, 72 (7). S. 1035 - 1043. HOBOKEN: WILEY. ISSN 1398-9995

Full text not available from this repository.

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. Conclusion: 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Pfaar, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Calderon, M. A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Andrews, C. P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Angjeli, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bergmann, K. C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bonlokke, J. H. UNSPECIFIED UNSPECIFIED UNSPECIFIED de Blay, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Devillier, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ellis, A. K. UNSPECIFIED UNSPECIFIED UNSPECIFIED van Wijk, R. Gerth UNSPECIFIED UNSPECIFIED UNSPECIFIED Hohlfeld, J. M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Horak, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jacobs, R. L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jacobsen, L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jutel, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaul, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Larche, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Larenas-Linnemann, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Moesges, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nolte, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Patel, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Peoples, L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rabin, R. L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rather, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Salapatek, A. M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sigsgaard, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Thaarup, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Yang, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zieglmayer, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zuberbier, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Demoly, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-227061
DOI:	10.1111/all.13133
Journal or Publication Title:	Allergy
Volume:	72
Number:	7
Page Range:	S. 1035 - 1043
Date:	2017
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1398-9995
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language POLLEN CHALLENGE CHAMBER; NASAL AIR-FLOW; GRASS-POLLEN; IMMUNOTHERAPY TRIALS; CLINICAL VALIDATION; SYMPTOM RELIEF; PLACEBO; EFFICACY; RHINITIS; UNIT Multiple languages Allergy; Immunology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/22706