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Allergy. 2017 May;72(5):713-722. doi: 10.1111/all.13092. Epub 2017 Jan 27.

Defining pollen exposure times for clinical trials of allergen immunotherapy for pollen-induced rhinoconjunctivitis - an EAACI position paper.

Author information

1
Department of Otorhinolaryngology, Head and Neck Surgery, Medical Faculty Mannheim, Universitätsmedizin Mannheim, Heidelberg University, Mannheim, Germany.
2
Center for Rhinology and Allergology, Wiesbaden, Germany.
3
Aerobiology and Pollen Information Research Unit, Department of Oto-Rhino-Laryngology, Medical University of Vienna, Vienna, Austria.
4
ZAUM, Center of Allergy & Environment, Helmholtz Center Munich/Technische Universität München, Member of the German Center for Lung Research (DZL), Munich, Germany.
5
Kühne Foundation, Christine Kühne-Center for Allergy Research and Education (CK-CARE), Munich, Germany.
6
Section of Allergy and Clinical Immunology, Imperial College London, London, UK.
7
National Heart & Lung Institute, Royal Brompton Hospital, London, UK.
8
Federal Office of Meteorology and Climatology MeteoSwiss, Payerne, Switzerland.
9
Department of Dermatology and Allergy Biederstein, Technical University of Munich (TUM), Munich, Germany.
10
Département de Pneumologie et Addictologie, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier, Montpellier, France.
11
UPMC Paris 06, UMR-S 1136, IPLESP, Equipe EPAR, Sorbonne Universités, Paris, France.
12
Department of Botany, Ecology and Plant Physiology, University of Córdoba, Córdoba, Spain.
13
Federal Office of Meteorology and Climatology MeteoSwiss, Zurich, Switzerland.
14
Section of Allergology, Department of Internal Medicine, Erasmus MC, Rotterdam, The Netherlands.
15
ALC, Allergy Learning and Consulting, Copenhagen, Denmark.
16
Finnish Meteorological Institute, Helsinki, Finland.
17
RNSA (Réseau National de Surveillance Aérobiologique), Brussieu, France.
18
Foundation German Pollen Information Service, Berlin, Germany.

Abstract

BACKGROUND:

Clinical efficacy of pollen allergen immunotherapy (AIT) has been broadly documented in randomized controlled trials. The underlying clinical endpoints are analysed in seasonal time periods predefined based on the background pollen concentration. However, any validated or generally accepted definition from academia or regulatory authorities for this relevant pollen exposure intensity or period of time (season) is currently not available. Therefore, this Task Force initiative of the European Academy of Allergy and Clinical Immunology (EAACI) aimed to propose definitions based on expert consensus.

METHODS:

A Task Force of the Immunotherapy and Aerobiology and Pollution Interest Groups of the EAACI reviewed the literature on pollen exposure in the context of defining relevant time intervals for evaluation of efficacy in AIT trials. Underlying principles in measuring pollen exposure and associated methodological problems and limitations were considered to achieve a consensus.

RESULTS:

The Task Force achieved a comprehensive position in defining pollen exposure times for different pollen types. Definitions are presented for 'pollen season', 'high pollen season' (or 'peak pollen period') and 'high pollen days'.

CONCLUSION:

This EAACI position paper provides definitions of pollen exposures for different pollen types for use in AIT trials. Their validity as standards remains to be tested in future studies.

KEYWORDS:

allergen immunotherapy; pollen concentration; pollen exposure; pollen season definition; randomized controlled trials

PMID:
27874202
DOI:
10.1111/all.13092
[Indexed for MEDLINE]

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