title: Validation of the Global Allergy and Asthma European Network (GA2LEN) chamber for trials in allergy: Innovation of a mobile allergen exposure chamber.
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.
authors.affiliation: 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: torsten.zuberbier@charite.de.
authors.forename: Torsten
authors.initials: T
authors.lastname: Zuberbier
authors.affiliation: Department of Ophthalmology, Harvard University, Andover, Mass.
authors.forename: Mark B
authors.initials: MB
authors.lastname: Abelson
authors.affiliation: Swiss Institute of Allergy and Asthma Research (SIAF), University of Zurich, Davos, Switzerland.
authors.forename: Cezmi A
authors.initials: CA
authors.lastname: Akdis
authors.affiliation: Upper Airway Research Laboratory, Ghent University, and Division of ENT Diseases, Clintec, Karolinska Institutet, Stockholm.
authors.forename: Claus
authors.initials: C
authors.lastname: Bachert
authors.affiliation: Aerobiology and Pollen Information Research Unit, Department of Oto-Rhino-Laryngology, Medical University of Vienna, Vienna, Austria.
authors.forename: Uwe
authors.initials: U
authors.lastname: Berger
authors.affiliation: Department of Dermatology and Allergy Center, Odense Research Center for Anaphylaxis, Odense University Hospital, Odense, Denmark.
authors.forename: Carsten
authors.initials: C
authors.lastname: Bindslev-Jensen
authors.affiliation: 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.
authors.forename: Georg
authors.initials: G
authors.lastname: Boelke
authors.affiliation: University Hospital, Montpellier, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Bousquet
authors.affiliation: Allergy & Respiratory Diseases Clinic, DIMI University of Genoa, IRCCS AOU San Martino, Genoa, Italy.
authors.forename: Giorgio Walter
authors.initials: GW
authors.lastname: Canonica
authors.affiliation: Division of Allergy and Immunology, University of South Florida, Tampa, Fla.
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Casale
authors.affiliation: ALL-MED Medical Research Institute, Wroclaw 2, Department of Clinical Immunology, Wroclaw Medical University, Wroclaw, Poland.
authors.forename: Marek
authors.initials: M
authors.lastname: Jutel
authors.affiliation: Department of Immunology, Rheumatology and Allergy, Medical University of Lodz, Lodz, Poland.
authors.forename: Marek L
authors.initials: ML
authors.lastname: Kowalski
authors.affiliation: Allergopharma S.p.A, Rome, Italy.
authors.forename: Enzo
authors.initials: E
authors.lastname: Madonini
authors.affiliation: Allergy Department, National Kapodistrian University of Athens, Athens, and the Division of Infection, Immunity & Respiratory Medicine, University of Manchester.
authors.forename: Nikolaos G
authors.initials: NG
authors.lastname: Papadopoulos
authors.affiliation: Center for Rhinology and Allergology, Wiesbaden, and the Department of Otorhinolaryngology, Head and Neck Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Pfaar
authors.affiliation: Bluestone Technology GmbH, Woerrstadt, Germany.
authors.forename: Torsten
authors.initials: T
authors.lastname: Sehlinger
authors.affiliation: 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.
authors.forename: Karl-Christian
authors.initials: KC
authors.lastname: Bergmann
mesh_terms: D000328:Adult; D000485:Allergens / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D019540:Area Under Curve; D005260:Female; D006801:Humans; D007158:Immunologic Techniques / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D006109:Poaceae / Q000009:adverse effects / Q000276:immunology*; D011058:Pollen / Q000009:adverse effects; D012372:ROC Curve; D006255:Rhinitis, Allergic, Seasonal / Q000175:diagnosis* / Q000276:immunology; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D000485:Allergens
keywords: Allergy trial; Global Allergy and Asthma European Network (GA(2)LEN); environmental exposure chamber; grasses; placebo; validation