Allergo Journal International

, Volume 26, Issue 8, pp 287–294 | Cite as

Technical specifications of the Global Allergy and Asthma European Network (GA2LEN) chamber: a novel mobile allergen exposure chamber

  • Torsten Voegler
  • Frank Goergen
  • Karl-Christian Bergmann
  • Georg Boelke
  • Joseph Salame
  • Julia Gildemeister
  • Torsten Zuberbier
original article

Abstract

Background

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.

Methods

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.

Results

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.

Conclusion

The GA2LEN chamber provides a novel mobile exposure chamber technology for research and clinical trials allowing a fast, affordable, and standardized multicenter approach.

Keywords

Allergen exposure chamber Technical validation Allergen immunotherapy Allergen provocation Allergy trial 

Notes

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.

Ethical standards

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.

Supplementary material

40629_2017_40_MOESM1_ESM.pdf (540 kb)
Table: Chamber technology used; Technical details about PDU, PLU and PCT; Fig. X: Technical drawing of independent particle disperse unit (PDU); Fig. Y: Image of particle containment tape (PCT); Fig. Z: Technical drawing of particle line unit (PLU)
40629_2017_40_MOESM2_ESM.jpg (1.5 mb)
Fig. Y: Image of particle containment tape (PCT)

References

  1. 1.
    Pawankar R, Canonica GW, Holgate ST, Lockey RF, Blaiss M. World Allergy Organization (WAO) White Book on Allergy: Update 2013. 2013.Google Scholar
  2. 2.
    Meltzer EO, Bukstein DA. The economic impact of allergic rhinitis and current guidelines for treatment. Ann Allergy Asthma Immunol. 2011;106:12–6.CrossRefGoogle Scholar
  3. 3.
    Small M, Piercy J, Demoly P, Marsden H. Burden of illness and quality of life in patients being treated for seasonal allergic rhinitis: a cohort survey. Clin Transl Allergy. 2013;3:33.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    D’Amato G, Cecchi L, D’Amato M, Liccardi G. Urban air pollution and climate change as environmental risk factors of respiratory allergy: an update. J Investig Allergol Clin Immunol. 2010;20:95–102.PubMedGoogle Scholar
  5. 5.
    Jacobs RL, Harper N, He W, Andrews CP, Rather CG, Ramirez DA, et al. Effect of confounding cofactors on responses to pollens during natural season versus pollen challenge chamber exposure. J Allergy Clin Immunol. 2014;133:1340–6.CrossRefPubMedGoogle Scholar
  6. 6.
    Day JH, Horak F, Briscoe MP, Canonica GW, Fineman SM, Krug N, et al. The role of allergen challenge chambers in the evaluation of anti-allergic medication: an international consensus paper. Clin Exp Allergy Rev. 2006;6:31–59.CrossRefGoogle Scholar
  7. 7.
    Rösner-Friese K, Kaul S, Vieths S, Pfaar O. Environmental exposure chambers in allergen immunotherapy trials: current status and clinical validation needs. J Allergy Clin Immunol. 2015;135:636–43.CrossRefPubMedGoogle Scholar
  8. 8.
    Werchan B, Werchan M, Mücke HG, Gauger U, Simoleit A, Zuberbier T, Bergmann KC. Spatial distribution of allergenic pollen through a large metropolitan area. Environ Monit Assess. 2017;189:169.CrossRefPubMedGoogle Scholar
  9. 9.
    Bastl K, Kmenta M, Jäger S, Bergmann KC, Berger U, European Aeroallergen Network. Development of a symptom load index: enabling temporal and regional pollen season comparisons and pointing out the need for personalized pollen information. Aerobiologia (Bologna). 2014;30:269–80.CrossRefGoogle Scholar
  10. 10.
    Simoleit S, Gauger U, Mücke HG, Werchan M, Obstova B, Zuberbier T, Bergmann KC. Intradiurnal patterns of allergenic airborne pollen near a city motorway in Berlin, Germany. Aerobiologia (Bologna). 2016;32:199–209.CrossRefGoogle Scholar
  11. 11.
    Bernstein JA. Correlation between a pollen challenge chamber and a natural allergen exposure study design for eliciting ocular and nasal symptoms: earl evidence supporting a paradigm shift in drug investigation? J Allergy Clin Immunol. 2012;130:128–9.CrossRefPubMedGoogle Scholar
  12. 12.
    Badorrek P, Dick M, Hecker H, Schaumann F, Sousa AR, Murdoch R, et al. Anti-allergic drug testing in an environmental challenge chamber is suitable both in and out of the relevant pollen season. Ann Allergy Asthma Immunol. 2011;106:336–41.CrossRefPubMedGoogle Scholar
  13. 13.
    Devillier P, Le Gall M, Horak F. The allergen challenge chamber: a valuable tool for optimizing the clinical development of pollen immunotherapy. Allergy. 2011;66:163–9.CrossRefPubMedGoogle Scholar
  14. 14.
    Horak F, Jäger S. Die Wiener Provokations-Kammer (Vienna Challenge Chamber). Eine neue Methode des Allergenexpositionstests. Wien Klin Wochenschr. 1987;99:509–10.Google Scholar
  15. 15.
    Krug N, Hohlfeld JM, Larbig M, Buckendahl A, Badorrek P, Geldmacher H, et al. Validation of an environmental exposure unit for controlled human inhalation studies with grass pollen in patients with seasonal allergic rhinitis. Clin Exp Allergy. 2003;33:1667–74.CrossRefPubMedGoogle Scholar
  16. 16.
    Del Cuvillo A, Sastre J, Bartra J, Mullol J, DaVila I, Montoro J, et al. Placebo effect in clinical trials involving patients with allergic rhinitis. J Investig Allergol Clin Immunol. 2011;21:40–5.PubMedGoogle Scholar
  17. 17.
    Pfaar O, Calderon MA, Andrews CP, Angjeli E, Bergmann KC, Bønløkke JH, et al. Allergen Exposure Chambers (AEC): harmonizing current concepts and projecting the needs for the future—an EAACI Position Paper. Allergy. 2017;72:1035–42.CrossRefPubMedGoogle Scholar
  18. 18.
    Goergen F, Sehlinger T. Method and device for controlled emission of particles. EU Patent EP3058866. 2015.Google Scholar
  19. 19.
    Goergen F, Sehlinger T. Method and device for controlled emission of particles. EU Patent EP3020435. 2015.Google Scholar
  20. 20.
    King EM, Filep S, Smith B, Duncan R, Block D, Armstrong J, Chapman MD. Quality control procedures using multiplex array for indoor allergens in an analytical laboratory. Eur J Allergy Clin Immunol. 2010;65:98.Google Scholar
  21. 21.
    GA2LEN EU Network of Excellence in Allergy and Asthma, Zuberbier T, Abelson MB, Akdis CA, Bachert C, Berger U, Bindslev-Jensen C, et al. Validation of the global allergy and asthma European network (GA2LEN) chamber for trials in allergy: innovation of a mobile allergen exposure chamber. J Allergy Clin Immunol. 2017;139:1158–66.CrossRefGoogle Scholar
  22. 22.
    Patel P, Nandkeshore H, Shields K. Mobile natural exposure chamber technology standardizes controlled environmental exposure chamber challenges across multicenter national and international allergy trials. J Allergy Clin Immunol. 2013;131:AB188.Google Scholar
  23. 23.
    Jacobs RL, Ramirez DA, Andrews CP. Validation of the biogenics research chamber for juniperus ashei (mountain cedar) pollen. Ann Allergy Asthma Immunol. 2011;107:133–8.CrossRefPubMedGoogle Scholar
  24. 24.
    Ito K, Terada T, Yuki A, Ichihara T, Hyo S, Kawata R, et al. Preliminary study of a challenge test to the patients with Japanese cedar pollinosis using an environmental exposure unit. Auris Nasus Larynx. 2010;37:694–9.CrossRefPubMedGoogle Scholar
  25. 25.
    Hamasaki S, Okamoto Y, Yonekura S, Okuma Y, Sakurai T, Iinuma T, et al. Characteristics of the chiba environmental challenge chamber. Allergol Int. 2014;63:41–50.CrossRefPubMedGoogle Scholar
  26. 26.
    Jacobs RL, Andrews CP, Ramirez DA, Rather CG, Harper N, Jimenez F, et al. Symptom dynamics during repeated serial allergen challenge chamber exposures to house dust mite. Allergy Clin Immunol. 2015;135:1071–5.CrossRefGoogle Scholar

Copyright information

© Springer Medizin Verlag GmbH 2017

Authors and Affiliations

  • Torsten Voegler
    • 1
  • Frank Goergen
    • 1
  • Karl-Christian Bergmann
    • 2
    • 3
  • Georg Boelke
    • 2
    • 3
  • Joseph Salame
    • 2
    • 3
  • Julia Gildemeister
    • 2
    • 3
  • Torsten Zuberbier
    • 2
    • 3
  1. 1.Bluestone TechnologyWoerrstadtGermany
  2. 2.Charité – Universitätsmedizin BerlinBerlinGermany
  3. 3.Department of Dermatology and Allergy, Allergy-Centre-CharitéCharité – Universitätsmedizin BerlinBerlinGermany

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