Validation of the Global Allergy and Asthma European Network (GA 2 LEN) chamber for trials in allergy: Innovation of a mobile allergen exposure chamber

Abstract

The mobility of the GALEN chamber provides a new, potentially effective, and safe way of generating reliable data in allergy multicenter clinical trials.

New European Academy of Allergy and Clinical Immunology definition on pollen season mirrors symptom load for grass and birch pollen‐induced allergic rhinitis

“…A similar situation occurred also concerning grass, where the increase in pollen levels at the end of June 2016 was not followed by an analogous increase in the TNSMS. Results are in line with allergen exposure chamber trials, as well as results about early and late pollen season‐related symptoms under natural (seasonal) exposure reported in.…”

Allergen exposure chambers: harmonizing current concepts and projecting the needs for the future – an EAACI Position Paper

“…If conditions are tightly controlled, repetition of the same protocol on separate occasions should yield the same results. This reproducibility has been reported with the Vienna Challenge Chamber (VCC) (Vienna, Austria), the EEC (Mississauga, Canada), the Environmental Exposure Unit (EEU) (Kingston, Canada), the Chamber at Department of Public Health, Aarhus University (Aarhus, Denmark), Biogenics Research Chamber LLC (San Antonio, TX, USA), Mobile Chamber Experts (MCX) (Berlin, Germany) and the Fraunhofer Allergen Challenge Chamber (Hannover, Germany) . Other facilities should publish their reproducibility data.…”

Perspectives in allergen immunotherapy: 2017 and beyond

“…However, the authors also emphasized the need for further clinical validation of AECs and grouped these clinical questions into the four domains “sensitivity/specificity of Allergic Rhinitis (AR) symptoms,” “reproducibility of AR symptoms and AIT treatment outcomes,” “correlation of AECs versus natural exposure regarding AR symptoms and AIT treatment outcomes” and “seasonal priming effects on AR symptoms and AIT treatment outcomes.” On the basis of this work, an interdisciplinary EAACI task force initiative comprising clinicians, regulators and AEC vendors has elaborated an EAACI Position Paper outlining (i) minimal standards regarding technical requisites (including standard operating procedures for operating and cleaning the chamber, use of GMP‐grade materials and known quantities of allergens); (ii) recommendations for model validation for conducting validation trials (including the use of standardized and clinically relevant outcome measures and defined safety measures); and (iii) prerequisites for clinical validation of AIT studies (primarily reproducibility) . The task force acknowledged that several of these minimal requirements have already been met but still important unmet needs for the future remain.…”