期刊
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
卷 135, 期 3, 页码 636-643出版社
MOSBY-ELSEVIER
DOI: 10.1016/j.jaci.2014.10.045
关键词
Environmental exposure chamber; allergen immunotherapy; clinical validation; pivotal studies
资金
- Monsanto Company
- Deutsche Dermatologische Gesellschaft
- Spanish Society of Allergy
- Clinical Immunology
- Schattauer Allergologie Handbuch
- Elsevier Nahrungscmittelaller-gien und Intoleranzen
- German Research Foundation
- Federal Institute for Risk Assessment
- Austrian Society for Allergology and Immunology
- European Directorate for the Quality of Medicines and Health Care
- European Academy of Allergy and Clinical Immunology
- World Allergy Organization
- Association Monegasque pour le Perfectionnement des Connaissances des Medicins
- Federal Office of Consumer Protection and Food Safety
- German Chemical Society (GDCh)
- Austrian Society for Dermatology and Venerology
- AKM Allergiekongress
- Austrian Food Chemical Society
- Allergopharma
- Bencard/Allergy Therapeutics
- HAL-Allergy
- Novartis/LETI
- MEDA
- ALK-Abello
- Biotech Tools s.a.
- GfK Bridgehead
- NAVIGANT consulting
- Sanofi
- Guidepoint Global Advisors,
- Thermo Fisher
- Stallergenes
- European Union [FP7-HEALTH]
- MEDA-Pharma GmbH
- Roxall
- Paul-Ehrlich-Institut
- GEKA mbH
- Bencard
- Novartis
As required by the European Medicines Agency and the US Food and Drug Administration for pivotal trials involving allergen immunotherapy (AIT) products, clinical efficacy assessment is currently based on double-blind, placebo-controlled field studies with natural allergen exposure during the allergen season. However, this study design is associated with several drawbacks, such as the high variability of allergen exposure in different trial sites or seasons and the presence of confounding environmental factors. On the contrary, environmental exposure chambers (EECs) aim to operate with a stable and reproducible allergen exposure under highly standardized environmental conditions. Technical validation parameters for different EECs worldwide have been published by several groups. However, full clinical validation of EEC study outcomes is required for their classification as an appropriate alternative to natural allergen exposure for AIT product efficacy assessment. Some clinical validation parameters have already been addressed for EEC units. The reliability of provoked symptoms in repeated EEC sessions is high, but the predictive power of EEC settings for the clinical response on natural exposure and the impact of seasonal priming on test results still have to be validated systematically, as does the inter-EEC variability. Thus the authors recommend a continued in-depth validation of EECs to exploit the potential of this technology for future AIT product development.
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