Validation of the Global Allergy and Asthma European Network (GA2LEN) chamber for trials in allergy: Innovation of a mobile allergen exposure chamber

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; Global Allergy and Asthma European Network (GA(2)LEN) European Union Network of Excellence in Allergy and Asthma

doi:10.1016/j.jaci.2016.08.025

Validation of the Global Allergy and Asthma European Network (GA²LEN) chamber for trials in allergy: Innovation of a mobile allergen exposure chamber

J Allergy Clin Immunol. 2017 Apr;139(4):1158-1166. doi: 10.1016/j.jaci.2016.08.025. Epub 2016 Sep 30.

Authors

Torsten Zuberbier¹, Mark B Abelson², Cezmi A Akdis³, Claus Bachert⁴, Uwe Berger⁵, Carsten Bindslev-Jensen⁶, Georg Boelke⁷, Jean Bousquet⁸, Giorgio Walter Canonica⁹, Thomas B Casale¹⁰, Marek Jutel¹¹, Marek L Kowalski¹², Enzo Madonini¹³, Nikolaos G Papadopoulos¹⁴, Oliver Pfaar¹⁵, Torsten Sehlinger¹⁶, Karl-Christian Bergmann⁷; Global Allergy and Asthma European Network (GA(2)LEN) European Union Network of Excellence in Allergy and Asthma

Affiliations

¹ Comprehensive Allergy-Centre-Charité, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Member of Global Allergy and Asthma European Network (GA(2)LEN), Berlin, Germany. Electronic address: [email protected].
² Department of Ophthalmology, Harvard University, Andover, Mass.
³ Swiss Institute of Allergy and Asthma Research (SIAF), University of Zurich, Davos, Switzerland.
⁴ Upper Airway Research Laboratory, Ghent University, and Division of ENT Diseases, Clintec, Karolinska Institutet, Stockholm.
⁵ Aerobiology and Pollen Information Research Unit, Department of Oto-Rhino-Laryngology, Medical University of Vienna, Vienna, Austria.
⁶ Department of Dermatology and Allergy Center, Odense Research Center for Anaphylaxis, Odense University Hospital, Odense, Denmark.
⁷ Comprehensive Allergy-Centre-Charité, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Member of Global Allergy and Asthma European Network (GA(2)LEN), Berlin, Germany.
⁸ University Hospital, Montpellier, France.
⁹ Allergy & Respiratory Diseases Clinic, DIMI University of Genoa, IRCCS AOU San Martino, Genoa, Italy.
¹⁰ Division of Allergy and Immunology, University of South Florida, Tampa, Fla.
¹¹ ALL-MED Medical Research Institute, Wroclaw 2, Department of Clinical Immunology, Wroclaw Medical University, Wroclaw, Poland.
¹² Department of Immunology, Rheumatology and Allergy, Medical University of Lodz, Lodz, Poland.
¹³ Allergopharma S.p.A, Rome, Italy.
¹⁴ Allergy Department, National Kapodistrian University of Athens, Athens, and the Division of Infection, Immunity & Respiratory Medicine, University of Manchester.
¹⁵ Center for Rhinology and Allergology, Wiesbaden, and the Department of Otorhinolaryngology, Head and Neck Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
¹⁶ Bluestone Technology GmbH, Woerrstadt, Germany.

PMID: 27697498
DOI: 10.1016/j.jaci.2016.08.025

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.

Keywords: Allergy trial; Global Allergy and Asthma European Network (GA(2)LEN); environmental exposure chamber; grasses; placebo; validation.

Publication types

Validation Study

MeSH terms

Adult
Allergens / administration & dosage*
Allergens / adverse effects
Allergens / immunology
Area Under Curve
Female
Humans
Immunologic Techniques / instrumentation*
Male
Middle Aged
Poaceae / adverse effects
Poaceae / immunology*
Pollen / adverse effects
ROC Curve
Rhinitis, Allergic, Seasonal / diagnosis*
Rhinitis, Allergic, Seasonal / immunology
Sensitivity and Specificity
Young Adult

Substances

Allergens