Health Effects of CREON2000 In Asthmatic Children

描述：（由申请人提供）：室内过敏原，包括霉菌和细菌副产物（例如，内毒素）具有作为保护剂对抗能够致敏和引起过敏和哮喘的过敏原的潜力。 该项目将通过对家庭中常见室内过敏原和微生物的前瞻性调查来证明概念。 一个独特的系统，长期的环境暴露评估相关的临床症状，肺功能和过敏原致敏与环境暴露的客观变化将被用来衡量一种新的紫外线（UV）空气修复系统的有效性。 初步证据表明，CREON 2000光子紫外线系统通过杀死霉菌孢子和细菌来消毒空气。 将选择20个患有6至12岁轻度持续性过敏性哮喘儿童的家庭参加这项为期6个月的双盲、安慰剂对照交叉试验。 最初，一半的家庭将有一个CREON 2000系统，另一半是一个假系统安装到各自的管道工程。 10周后，将更换这些系统。 在入组前，将通过皮肤点刺试验对常年性过敏原（至少一种室内霉菌和一种其他常年性室内过敏原）确认受试者的过敏致敏性，并通过客观肺功能试验（一秒钟内用力呼气量（FEV-1）变化12-15%）确认气道受限。 参与者的基线评估将包括全面的家庭和学校环境史、疾病特异性和非特异性生活质量问卷和体格检查。 将在基线、第8周和第22周进行为期两周的长期环境暴露评估。 环境暴露评估将包括空气和沉降灰尘样本，以分析过敏原（尘螨、猫、狗、蟑螂和曲霉菌、青霉菌、枝孢菌和交链孢霉孢子）以及儿童卧室中的细菌和内毒素水平。 同时采集室外空气样本。流浪汉电子数据采集器（Scott Technical Instruments Ltd.）将用于监测整个研究期间的环境条件。 成功完成本研究后，下一步将包括一项更大的前瞻性临床试验，以调查哮喘儿童在家中长期使用CREON 2000后的长期（超过12个月）健康结果，并对紫外线辐射是否以及如何改变蛋白质过敏性进行更详细的调查。

DESCRIPTION: (provided by applicant): Indoor allergens including molds and bacterial byproducts (e.g., endotoxin) have the potential to act as protective agents versus allergens capable of sensitizing and causing allergies and asthma. This project will demonstrate proof of concept through a prospective investigation of exposure to common indoor allergens and microorganisms in the home. A unique system of prolonged environmental exposure assessment which correlates clinical symptoms, objective changes in lung function and allergen sensitization with environmental exposure will be used to measure the effectiveness of a novel ultraviolet (UV) air remediation system. Preliminary evidence indicates that the CREON2000 Photonic UV system disinfects the air it treats by killing mold spores and bacteria. Twenty households with a mild-persistent allergic asthmatic child between the ages of 6 and 12 will be selected to participate in this six-month double blind, placebo-controlled crossover trial. Initially half of the homes will have a CREON2000 system and the other half a sham system installed into their respective duct works. At 10 weeks, these systems will be exchanged. Prior to enrollment, allergic sensitization of participants will be confirmed by skin prick testing to perennial allergens (at least one indoor mold and one other perennial indoor allergen) and airway limitation by objective pulmonary function testing (a 12-15% change in forced expiratory volume in one second (FEV-1). Baseline assessment of participants will include a thorough home and school environmental history, disease specific and non-specific quality of life questionnaires and physical examination. A two-week, prolonged environmental exposure assessment will be performed at baseline, 8 weeks and 22 weeks. Environmental exposure assessment will include air and settled dust samples to analyze allergens (dust mite, cat, dog, cockroach and Aspergillus, Penicillium, Cladosporium and Alternaria mold spores) and bacterial and endotoxin levels in the child's bedroom. Outdoor air samples will be collected simultaneously. HOBO electronic data collectors (Scott Technical Instruments Ltd.) will be used to monitor environmental conditions throughout the study. Upon successful completion of this study, the next steps will include a larger prospective clinical trial to investigate long-term (more than12 months) health outcomes of asthmatic children after prolonged use of the CREON2000 in the home and conduct more detailed investigation of whether and how UV radiation alters protein allergenicity.