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

Autor: Oliver Pfaar, Enzo Madonini, Torsten Zuberbier, Nikolaos G. Papadopoulos, Giorgio Walter Canonica, Georg Boelke, Cezmi A. Akdis, Claus Bachert, Jean Bousquet, Marek Jutel, Uwe Berger, Marek L. Kowalski, Mark B. Abelson, Carsten Bindslev-Jensen, Thomas B. Casale, Torsten Sehlinger, Karl-Christian Bergmann
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Male
0301 basic medicine
Allergy
POLLEN CHALLENGE CHAMBER
Pollen/adverse effects
medicine.disease_cause
Global Allergy and Asthma European Network (GA(2)LEN)
0302 clinical medicine
Allergen
DESIGN
Medicine and Health Sciences
Immunology and Allergy
Allergens/administration & dosage
Poaceae/adverse effects
validation
IMMUNOTHERAPY TRIALS
PLACEBO
Environmental exposure
Middle Aged
Allergy trial
Global Allergy and Asthma European Network (GA2LEN)
Area Under Curve
Female
Global Allergy and Asthma European Network (GA LEN)
Adult
Allergen immunotherapy
medicine.medical_specialty
Visual analogue scale
Immunology
Placebo
Sensitivity and Specificity
Young Adult
03 medical and health sciences
Environmental exposure chamber
Grasses
Validation
PATENCY
medicine
Humans
Asthma
Rhinitis
Allergic
Seasonal/diagnosis
business.industry
RHINITIS
medicine.disease
EFFICACY
Clinical trial
RHINOCONJUNCTIVITIS
030104 developmental biology
grasses
SEVERITY
ROC Curve
030228 respiratory system
NASAL INSPIRATORY FLOW
Emergency medicine
placebo
Immunologic Techniques/instrumentation
business
environmental exposure chamber
Zdroj: JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
Zuberbier, T, Abelson, M B, Akdis, C A, Bachert, C, Berger, U, Bindslev-Jensen, C, Boelke, G, Bousquet, J, Canonica, G W, Casale, T B, Jutel, M, Kowalski, M L, Madonini, E, Papadopoulos, N G, Pfaar, O, Sehlinger, T, Bergmann, K-C & GALEN EU Network of Excellence in Allergy and Asthma 2017, ' Validation of the Global Allergy and Asthma European Network (GA 2 LEN) chamber for trials in allergy : Innovation of a mobile allergen exposure chamber ', Journal of Allergy and Clinical Immunology, vol. 139, no. 4, 1158–1166, pp. 1158-1166 . https://doi.org/10.1016/j.jaci.2016.08.025
ISSN: 0091-6749
Popis: 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 (GA 2LEN) 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 GA 2LEN 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 2LEN chamber. No adverse reactions were recorded during the tests. Conclusions The mobility of the GA 2LEN chamber provides a new, potentially effective, and safe way of generating reliable data in allergy multicenter clinical trials.
Databáze: OpenAIRE
Externí odkaz: