Journal of Asthma and Allergy (Dec 2016)
Technical and clinical validation of an environmental exposure unit for ragweed
Abstract
Paul J Gomes,1 Keith J Lane,1 Endri Angjeli,1 Linda Stein,1 Mark B Abelson1,2 1Ora, Inc., Andover, MA, USA; 2Department of Ophthalmology, Harvard Medical School, Cambridge, MA, USA 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.Conclusion: 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. Keywords: Allergen BioCube®, validation, ragweed, symptom response, exposure unit
