Validation of the GA2LEN chamber for trials in allergy: Innovation of a mobile allergen exposure chamber

Publication date: Available online 30 September 2016
Source:Journal of Allergy and Clinical Immunology
Author(s): Torsten Zuberbier, Mark B. Abelson, Cezmi A. Akdis, Claus Bachert, Uwe Berger, Carsten Bindslev-Jensen, Georg Boelke, Jean Bousquet, Giorgio Walter Canonica, Thomas B. Casale, Marek Jutel, Marek L. Kowalski, Enzo Madonini, Nikolaos G. Papadopoulos, Oliver Pfaar, Torsten Sehlinger, Karl-Christian Bergmann
BackgroundField clinical trials of pollen allergy are impacted by the impossibility to predict and to determine individual allergen exposure, due to many factors (e.g., pollen season, atmospheric variations, pollutants, lifestyles). Environmental exposure chambers (EEC), delivering a fixed amount of allergens in a controlled environmental setting, can overcome these limitations. EECs 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 GA²LEN mobile exposure chamber is a step forward, since the mobility of the chamber makes it convenient for patients to participate in clinical testing.ObjectiveThis study was made to validate the reproducibility, sensitivity, and specificity of the results obtained in the new GA²LEN chamber.MethodsSeventy-two adult patients (19–61 years), with allergic rhinitis with/without asthma due to grass pollen, were included in different clinical validation tests. Total Symptom Scores (TSS) and Total Nasal Symptom Scores (TNSS) were recorded at time zero (0), and every 10 minutes during exposures, along with nasal and respiratory parameters.ResultsExposure tests confirmed the reproducibility between subsequent runs, the sensitivity (p <0.00001 vs. patients exposed to placebo) and the specificity (very low score in nonallergic subjects) in the GA²LEN chamber. No adverse reactions were recorded during the tests.ConclusionsThe mobility of the GA²LEN chamber provides a new, potentially effective, and safe way of generating reliable data in allergy multicenter clinical trials.

Teaser

The novel GA²LEN chamber has been technically and clinically validated in grass-allergic patients to allow multicenter trials in allergy with a mobile environmental exposure chamber.


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