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Validation of the GA(2)LEN chamber for trials in allergy

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Validation of the GA(2)LEN chamber for trials in allergy
Zuberbier, Torsten ; Abelson, Mark B ; Akdis, Cezmi A ; Bachert, Claus ; Berger, Uwe ;Bindslev-Jensen, Carsten ; Boelke, Georg ; Bousquet, Jean ; Canonica, Giorgio Walter ;Casale, Thomas B ; Jutel, Marek ; Kowalski, Marek L ; Madonini, Enzo ;Papadopoulos, Nikolaos G ;
(Journal of Allergy and Clinical Immunology, 2017, Vol 139, Issue 4

 

BACKGROUND: Field 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 GA(2)LEN mobile exposure chamber is a step forward, since 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 GA(2)LEN chamber. METHODS: Seventy-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.
RESULTS: Exposure 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 GA(2)LEN chamber. No adverse reactions were recorded during the tests.
CONCLUSIONS: The mobility of the GA(2)LEN chamber provides a new, potentially effective, and safe way of generating reliable data in allergy multicenter clinical trials.<?XML:NAMESPACE PREFIX = O />

 
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