Health Effects of CREON2000 In Asthmatic Children

CREON2000 对哮喘儿童的健康影响

• 批准号: 6582354
• 负责人: Mark Glazman
• 金额: $ 17.11万
• 依托单位: GENERAL INNOVATIONS AND GOODS, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-02-15 至 2004-08-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6582354
• 关键词: air sampling /monitoring; air treatment; airborne allergen; asthma; clinical research; data collection; disinfectants; dust; endotoxins; environmental exposure; human subject; lung; middle childhood (6-11); personal log /diary; pollution related respiratory disorder; pulmonary respiration; questionnaires; respiratory function; technology /technique development; ultraviolet radiation

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.

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）有可能作为保护剂，对抗能够致敏并引起过敏和哮喘的过敏原。该项目将通过对家庭中常见的室内过敏原和微生物暴露的前瞻性调查来证明概念的证明。一种独特的长时间环境暴露评估系统将临床症状、肺功能的客观变化和过敏原致敏性与环境暴露相关联，用于测量新型紫外线（UV）空气修复系统的有效性。初步证据表明，CREON2000光子紫外线系统通过杀死霉菌孢子和细菌对其处理的空气进行消毒。20个有6至12岁轻度持续性过敏性哮喘儿童的家庭将被选中参加这项为期6个月的双盲、安慰剂对照交叉试验。最初，一半的家庭将安装CREON2000系统，另一半家庭将在各自的管道系统中安装假系统。10周后，这些系统将被交换。在入组前，参与者的过敏致敏性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另一种常年性室内过敏原）和气道限制进行客观肺功能测试（一秒钟用力呼气量变化12-15% (FEV-1)）确认。对参与者的基线评估将包括全面的家庭和学校环境史，特定疾病和非特定疾病的生活质量问卷调查和体格检查。将在基线、8周和22周时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淀灰尘样本，以分析过敏原（尘螨、猫、狗、蟑螂和曲霉、青霉菌、枝孢菌和Alternaria霉菌孢子）以及孩子卧室中的细菌和内毒素水平。同时采集室外空气样本。HOBO电子数据采集器（Scott技术仪器有限公司）将用于监测整个研究过程中的环境状况。在这项研究成功完成后，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CREON2000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原进行更详细的调查。