Health Effects of CREON2000 in Asthmatic Children

描述(申请人提供)：这项试验的目的是研究CREON2000A在改善哮喘控制和预防或减少轻至中度过敏性哮喘儿童哮喘事件方面的有效性。获得专利的CREON2000A设备正在开发中，作为一种环境控制干预措施，将作为哮喘的辅助治疗。紧凑型节能设计允许95%的1994年后建造的家庭和74%的美国家庭使用该设备。根据这一统计数据，CREON2000A干预措施如果有效，可能会使美国大多数哮喘儿童受益。我们初步的SBIR第一阶段研究有希望的结果值得在更大的临床试验中对该设备进行进一步的研究。本临床试验设计为II期、多中心、12个月、双盲、随机、假对照、平行分组研究。它比较了居住在CREON2000A照射系统家庭中的轻度至中度过敏性持续性哮喘儿童与生活在假家庭中的儿童在哮喘控制方面的改善，这是通过哮喘控制问卷衡量的。这项试验的次要终点是：晨峰呼气流速，减少吸入总次数 抢救药物，哮喘加重，缺课或缺勤的日子。这项试验包括一个探索性目标，旨在调查CREON2000A的作用机制是否与紫外线照射导致的蛋白质结构变化有关，从而降低室内过敏原的过敏性。一个由经验丰富的大学和小企业为基础的研究人员组成的跨学科团队，具有必要的技术和临床专业知识，已经被召集起来研究这一潜在的重要的哮喘控制干预措施。目前治疗哮喘的方法非常昂贵。2006年，80亿美元用于治疗儿童哮喘。根据国家哮喘指南的建议，每名儿童实施多方面环境控制干预措施的年费用在750美元至1,000美元之间，这与哮喘药物的年费用相当。有必要改变父母的行为，这样他们才能维持耗时且往往昂贵的干预措施，这为遵守这些建议制造了巨大的障碍。CREON2000A设备只需最少的维护(即一年更换一次灯泡和小过滤器)，并且因为它使用简单，住户不必改变他们的日常生活。出于这个原因，这种干预的可接受性和耐心依从性是极好的。包括CREON2000A机组在10年内摊销在内，这一干预措施的预计年度成本为244美元。因此，这种设备和技术的应用可以优化哮喘的医疗管理，从而显著降低与治疗这种慢性病相关的成本。

DESCRIPTION (provided by applicant): The purpose of this trial is to investigate the effectiveness of the CREON2000A for improving asthma control and preventing or reducing asthma events in children with mild to moderate allergic asthma. The patented CREON2000A device is being developed as an environmental control intervention that will serve as an adjunctive treatment of asthma. The compact energy efficient design allows the use of the device in 95% of homes built after 1994, and in 74% of all US homes. Based on this statistics, the CREON2000A intervention, if efficacious, could benefit the majority of children with asthma in the United States. The promising results of our preliminary SBIR Phase I study warrant further investigation of this device in a larger clinical trial. This clinical trial is designed asa Phase II, multicenter, twelve month, double blind, randomized, sham controlled, parallel group study. It compares improvement in asthma control, as measured by the Asthma Control Questionnaire, in mild to moderate allergic persistent asthmatic children living in homes with a CREON2000A Irradiation system to those living in homes with sham units. Secondary endpoints of this trial are: morning peak expiratory flow rates, a reduction of total number of inhalation of rescue medications, asthma exacerbations, and missed days from school or work. The trial includes an exploratory objective designed to investigate whether CREON2000A's mechanism of action is related to protein structural changes by UV irradiation leading to the decreased allergenicity of indoor allergens. An interdisciplinary team of experienced, university and small business based researchers, with the necessary technical and clinical expertise has been assembled to investigate this potentially important asthma control intervention. The current approach for the management of asthma is very costly. In 2006, 8 billion dollars was spent treating childhood asthma. The annual cost per child for implementing multifaceted environmental control interventions, as recommended by the national asthma guidelines, ranges between $750 to $1,000 which is comparable to the annual cost of asthma medications. The necessity to modify behavior of parents, so they will maintain time-consuming and often expensive interventions, creates a significant barrier for adhering to these recommendations. The CREON2000A device requires minimal maintenance (i.e., changing bulb and small filter once a year) and, because it is simple to use, home occupants do not have to change their daily routines. For that reason, the acceptability and patient adherence with this intervention is excellent. The projected annual cost of this intervention including the amortization of the CREON2000A unit over 10 years is $244. Therefore, the application of this device and technology could optimize the medical management of asthma leading to a significant reduction in the costs associated with treating this chronic disease.