title: Technical and clinical validation of an environmental exposure unit for ragweed.
abstract: BACKGROUND
  Allergic rhinitis is a common condition, with ragweed pollen one of the more prevalent aeroallergens. Environmental exposure units such as the Allergen BioCube®are valuable models for clinical allergy studies. A study was conducted to validate the Allergen BioCube for uniform ragweed pollen concentrations and clinically relevant sign and symptom responses to ragweed exposure.
  
  
  METHODS
  Ragweed pollen concentrations were measured on 3 consecutive days in the Allergen BioCube and verified by Rotorod collection and continuous laser particle count measurements. Subjects (N=10) were exposed to ragweed pollen in the BioCube for 3 hours per day for 3 consecutive days. Subjects assessed their nasal itching, sneezing, rhinorrhea, and nasal congestion during each BioCube exposure; total nasal symptom score was computed. Peak nasal inspiratory flow was also assessed during BioCube exposure.
  
  
  RESULTS
  Uniform ragweed pollen concentrations were obtained throughout each of the 3-hour testing periods in the Allergen BioCube, both spatially and temporally, at all subject positions, with a low mean standard deviation of 10%. Pronounced increases in mean total nasal symptom scores (6.7±0.94 to 7.6±0.86, last 90 minutes of exposure) occurred for all three BioCube ragweed pollen exposure visits. Mean peak nasal inspiratory flow decreased 24% at 3 hours of BioCube exposure on Day 3. No safety issues of concern occurred in this study.
  
  
  CONCLUSIONS
  The Allergen BioCube achieved technical and clinical validation for ragweed allergen. Ragweed pollen concentration was uniform both temporally and spatially. Allergic rhinitis signs and symptoms were induced in subjects during exposure to ragweed in the BioCube at clinically meaningful levels for allergy studies.
authors.affiliation: Ora, Inc., Andover, MA, USA.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Gomes
authors.affiliation: Ora, Inc., Andover, MA, USA.
authors.forename: Keith J
authors.initials: KJ
authors.lastname: Lane
authors.affiliation: Ora, Inc., Andover, MA, USA.
authors.forename: Endri
authors.initials: E
authors.lastname: Angjeli
authors.affiliation: Ora, Inc., Andover, MA, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Stein
authors.affiliation: Ora, Inc., Andover, MA, USA; Department of Ophthalmology, Harvard Medical School, Cambridge, MA, USA.
authors.forename: Mark B
authors.initials: MB
authors.lastname: Abelson
keywords: Allergen BioCube®; exposure unit; ragweed; symptom response; validation