Validation of the Global Allergy and Asthma European Network (GA2LEN) chamber for trials in allergy: Innovation of a mobile allergen exposure chamber - 19/04/17
, Mark B. Abelson, MD b, Cezmi A. Akdis, MD c, Claus Bachert, MD, PhD d, Uwe Berger, MBA e, Carsten Bindslev-Jensen, MD f, Georg Boelke, MD a, Jean Bousquet, MD g, Giorgio Walter Canonica, MD h, Thomas B. Casale, MD i, Marek Jutel, MD j, Marek L. Kowalski, MD k, Enzo Madonini, MD l, Nikolaos G. Papadopoulos, MD m, Oliver Pfaar, MD n, Torsten Sehlinger o, Karl-Christian Bergmann, MD afor the
Global Allergy and Asthma European Network (GA2LEN) European Union Network of Excellence in Allergy and Asthma
Abstract |
Background |
Field clinical trials of pollen allergy are affected by the impossibility of predicting and determining individual allergen exposure because of many factors (eg, pollen season, atmospheric variations, pollutants, and lifestyles). Environmental exposure chambers, delivering a fixed amount of allergen in a controlled environmental setting, can overcome these limitations. Environmental exposure chambers are currently already used in phase 2, 3, and even 4 trials. Unfortunately, few chambers exist in the world, and this makes it difficult to perform large, multicenter clinical trials. The new Global Allergy and Asthma European Network (GA2LEN) mobile exposure chamber is a step forward because the mobility of the chamber makes it convenient for patients to participate in clinical testing.
Objective |
This study was made to validate the reproducibility, sensitivity, and specificity of the results obtained in the new GA2LEN chamber.
Methods |
Seventy-two adult patients (19-61 years old) with allergic rhinitis with or without asthma caused by grass pollen were included in different clinical validation tests. Total symptom scores and total nasal symptom scores were recorded at time zero (0) and every 10 minutes during exposures, along with nasal and respiratory parameters.
Results |
Exposure tests confirmed the reproducibility between subsequent runs and the sensitivity (P < .00001 vs patients exposed to placebo) and specificity (very low score in nonallergic subjects) in the GA2LEN chamber. No adverse reactions were recorded during the tests.
Conclusions |
The mobility of the GA2LEN chamber provides a new, potentially effective, and safe way of generating reliable data in allergy multicenter clinical trials.
Le texte complet de cet article est disponible en PDF.Key words : Allergy trial, environmental exposure chamber, validation, grasses, placebo, Global Allergy and Asthma European Network (GA2LEN)
Abbreviations used : AIT, AUC, EEC, GA2LEN, PDU, PNIF, TNSS, TSS, VAS
Plan
| Supported by GA2LEN and Mobile Chamber Experts. |
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| Disclosure of potential conflict of interest: T. Zuberbier has received institutional funding for research and/or honoria for lectures and/or consulting from AstraZeneca, AbbVie, ALK, Almirall, Astellas, Bayer Health Care, Bencard, Berlin Chemie, FAES, HAL, Henkel, Kryolan, Leti, L'Oreal, Meda, Menarini, Merck, MSD, Novartis, Pfizer, Sanofi, Stallergenes, Takeda, Teva and UCB; in addition, he is a member of ARIA/WHO, DGAKI, ECARF, GA2LEN and WAO. M. B. Abelson has received board membership from Ora, employment by Ora, and royalties from Allergan. C. A. Akdis has received consultancy fees from Actellion, Aventis, Stallergenes, Allergopharma, and Circacia; employment from the Swiss Institute of Allergy and Asthma Research, University of Zurich, Switzerland, and money paid to his institution from Novartis Research on immunoregulation in asthma, PREDICTA: European Commission's Seventh Framework programme no. 260895 “Research on virus induced exacerbations,” Swiss National Science Foundation Research on T cell interaction with the epithelium, MeDALL: European Commission's Seventh Framework Programme no. 261357 Research on early initiation of asthma, and the Christine Kühne-Center for Allergy Research and Education Research on severe allergies. U. Berger has received consultancy fees from Bencard, employment from the Medical University of Vienna, was paid for expert testimony by Philips, received grants from the European Union, and received payment for lectures form Bencard. C. Bindslev-Jensen or his institution has received consultancy fees from Thermo Fisher, Novartis, Hal allergy, and Anergis and received payment for lectures from MEDA, Faies, HAL Allergy, and Thermo Fisher. J. Bousquet has relevant financial activities outside the submitted work as follows: member of scientific and advisory boards for Actelion, Almirall, MEDA, Merck, MSD, Novartis, Sanofi-Aventis, Takeda, Teva, and Uriach; received fees for lectures during meetings from Almirall, AstraZeneca, Chiesi, GlaxoSmithKline, MEDA, Merck, MSD, Novartis, OM Pharma, Sanofi-Aventis, Schering Plough, Takeda, Teva, and Uriach; and member of the Board of Directors of Stallergenes. T. B. Casale has received consultancy fees from ORA and grants from ORA. M. Jutel has received board membership from Allergopharma, Anergis, and the Polish National Science Centre; received consultancy fees from Allergopharma, Anergis, and Europharma; received grants from the Polish National Science Centre, Anergis, and GlaxoSmithKline; received payment for lectures from Allergopharma, Stallergenes, ALK-Abelló, and the American Academy of Allergy, Asthma & Immunology; and received travel expenses from the European Academy of Allergy and Clinical Immunology. E. Madonini has received consultancy fees and payment for manuscripts from Allergopharma S.p.A and Allergopharma. N. G. Papadopoulos has received payment for relevant financial activities outside the submitted work from Abbvie, Novartis, Faes Farma, Biomay, MEDA, Menarini, ALK-Abelló, Chiesi, and Stallergenes and received grants from Nestec and Merck Sharp & Dohme. O. Pfaar has received payment out of the submitted work for consultancy from HAL Allergy, Allergy Therapeutics, Bencard, Novartis, LETI, MEDA, ALK-Abelló, Anergis, Biotech Tools, Sanofi-Aventis, Mobile Chamber Experts (a GA2LEN partner), Pohl-Boskamp, Stallergenes and Lofarma; has received grants paid to him or his institution from ALK-Abelló, Allergopharma, Stallergenes, HAL Allergy, Allergy Therapeutics, Bencard, Lofarma, Novartis, LETI, Biomay, Nuvo, Circassia, and Biotech Tools; has received payment for lectures from HAL Allergy, Bencard, Novartis, LETI, MEDA, ALK-Abelló, Allergopharma, Lofarma, and Stallergenes; has received payment for development of educational presentations from Allergopharma, Novartis, ALK-Abelló, and Stallergenes; has received travel expenses paid by HAL Allergy; and he is the current chairman of the Immunotherapy Interest Group (IT IG) of the European Academy of Allergy and Clinical Immunology (EAACI), member of the extended board of German Society for Allergology and Clinical Immunology (DGAKI) and the secretary of the ENT section of the DGAKI and chairman or member of different guideline-/task force initiatives of EAACI and DGAKI. T. Sehlinger has received payment to his institution for work under consideration from Mobile Chamber Expects GmbH and consultancy fees paid to his institution from Mobile Chamber Experts GmbH. K.-C. Bergmann has received reimbursement for travel costs and employment for this work. The rest of the authors declare that they have no conflict of interest. |
Vol 139 - N° 4
P. 1158-1166 - avril 2017 Retour au numéro
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