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. 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: torsten.zuberbier@charite.de. 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.
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.
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: Sarah K Wise; Sandra Y Lin; Elina Toskala; Richard R Orlandi; Cezmi A Akdis; Jeremiah A Alt; Antoine Azar; Fuad M Baroody; Claus Bachert; G Walter Canonica; Thomas Chacko; Cemal Cingi; Giorgio Ciprandi; Jacquelynne Corey; Linda S Cox; Peter Socrates Creticos; Adnan Custovic; Cecelia Damask; Adam DeConde; John M DelGaudio; Charles S Ebert; Jean Anderson Eloy; Carrie E Flanagan; Wytske J Fokkens; Christine Franzese; Jan Gosepath; Ashleigh Halderman; Robert G Hamilton; Hans Jürgen Hoffman; Jens M Hohlfeld; Steven M Houser; Peter H Hwang; Cristoforo Incorvaia; Deborah Jarvis; Ayesha N Khalid; Maritta Kilpeläinen; Todd T Kingdom; Helene Krouse; Desiree Larenas-Linnemann; Adrienne M Laury; Stella E Lee; Joshua M Levy; Amber U Luong; Bradley F Marple; Edward D McCoul; K Christopher McMains; Erik Melén; James W Mims; Gianna Moscato; Joaquim Mullol; Harold S Nelson; Monica Patadia; Ruby Pawankar; Oliver Pfaar; Michael P Platt; William Reisacher; Carmen Rondón; Luke Rudmik; Matthew Ryan; Joaquin Sastre; Rodney J Schlosser; Russell A Settipane; Hemant P Sharma; Aziz Sheikh; Timothy L Smith; Pongsakorn Tantilipikorn; Jody R Tversky; Maria C Veling; De Yun Wang; Marit Westman; Magnus Wickman; Mark Zacharek Journal: Int Forum Allergy Rhinol Date: 2018-02 Impact factor: 3.858
Authors: Karl-Christian Bergmann; Linda Krause; Julia Hiller; Sylvia Becker; Sebastian Kugler; Martin Tapparo; Oliver Pfaar; Torsten Zuberbier; Matthias F Kramer; Sonja Guethoff; Anke Graessel Journal: World Allergy Organ J Date: 2020-12-18 Impact factor: 4.084