Technical specifications of the Global Allergy and Asthma European Network (GA2LEN) chamber: a novel mobile allergen exposure chamber
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Field trials are the traditional approach for clinical trials in allergy but are under criticism for lack of standardization as they are affected by uncontrollable parameters such as environmental conditions, pollen counts, or lifestyle. Stationary allergen exposure chambers with a defined concentration of allergens under stable and standardized environmental conditions have been used to overcome these restrictions but have not allowed multicenter studies. We here describe the technical specifications and validation of a novel mobile pollen chamber specifically designed for multicenter studies—the GA2LEN chamber.
Two inter-connectable standard-sized container frames were used as a structural basis for the newly developed allergen exposure chamber. One container accommodates an observation room, also used as an office, and a changing room. The other container houses the test chamber itself and the technical installations. A customized air condition system was integrated and several environmental sensors were installed in the test chamber. Environmental tests have been performed at various outside conditions. The airflow in the test chamber was designed to prevent unspecific symptoms. To allow for an individual particle exposure at each seat, a new particle disperse and distribution system was developed, patented and validated.
Technical and clinical validation tests have been successfully performed with Phleum pratense, Betula pendula, and mixtures of Dermatophagoides farinae, and Dermatophagoides pteronyssinus. The newly developed particle disperse system enable individual verum and placebo exposure, an even particle distribution at every seating position. The built-in air-conditioner is able to generate a tightly controlled, standardized and comfortable environment and the airflow did not provoke clinically significant irritation to lower respiratory tract, nose, or eyes. The chamber transportation has proven to be flexible and cost-effective.
The GA2LEN chamber provides a novel mobile exposure chamber technology for research and clinical trials allowing a fast, affordable, and standardized multicenter approach.
KeywordsAllergen exposure chamber Technical validation Allergen immunotherapy Allergen provocation Allergy trial
Compliance with ethical guidelines
Conflict of interest
F. Goergen reports other payments from Bluestone Technology GmbH, a Mobile Chamber Experts GmbH supplier, during the conduct of the study; in addition, Mr. Goergen has a patent DE 102014116694 issued, and a patent DE102015102492 pending. T. Voegler reports personal fees and other payments from Mobile Chamber Experts GmbH, during the conduct of the study; In addition, Mr. Voegler has a patent DE 102014116694 issued, and a patent DE102015102492 pending. K.-C. Bergmann reports personal fees from Mobile Chamber Expert GmbH, during the conduct of the study; personal fees from Mobile Chamber Experts GmbH for traveling, outside the submitted work. G. Boelke reports grants from ALK-Abelló „Förderpreis Allergologie 2015“, during the conduct of the study; personal fees from Mobile Chamber Experts GmbH, outside the submitted work. T. Zuberbier has received personal fees from AstraZeneca, AbbVie, ALK, Almirall, Astellas, Bayer Health Care, Bencard, Berlin Chemie, FAES, HAL, Leti, Meda, Menarini, Merck, MSD, Novartis, Pfizer, Sanofi, Stallergenes, Takeda, Teva, UCB, Kryolan and L’Oreal. Dr. T. Zuberbier has received grants from Henkel and Novartis. J. Gildemeister reports personal fees as an employee from Mobile Chamber Expert GmbH, during the conduct of the study. J. Salame declares that he has no competing interests.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.
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