Technical and clinical validation of an environmental exposure unit for ragweed
| Autor: | Mark B. Abelson, Endri Angjeli, Linda Stein, Keith Jeffrey Lane, Paul J Gomes |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Pulmonary and Respiratory Medicine
Ragweed Allergy Allergen BioCube® exposure unit Nasal congestion medicine.disease_cause 03 medical and health sciences 0302 clinical medicine Allergen medicine Journal of Asthma and Allergy otorhinolaryngologic diseases Immunology and Allergy 030223 otorhinolaryngology ragweed Original Research validation rhinorrhea biology business.industry symptom response Environmental exposure medicine.disease biology.organism_classification Ragweed pollen 030228 respiratory system Immunology Peak Nasal Inspiratory Flow medicine.symptom business |
| Zdroj: | Journal of Asthma and Allergy |
| ISSN: | 1178-6965 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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