Health Effects of CREON2000 in Asthmatic Children

描述（由申请方提供）：本试验的目的是研究CREON 2000A在轻度至中度过敏性哮喘儿童中改善哮喘控制和预防或减少哮喘事件的有效性。专利CREON 2000A设备正在开发作为一种环境控制干预，将作为哮喘的预防性治疗。紧凑的节能设计允许在95%的1994年以后建造的家庭中使用该设备，并在74%的美国家庭中使用。根据这些统计数据，CREON 2000A干预措施如果有效，可以使美国大多数哮喘儿童受益。我们的初步SBIR I期研究的有希望的结果保证了在更大的临床试验中对该器械进行进一步研究。本临床试验设计阿萨II期、多中心、12个月、双盲、随机、假手术对照、平行组研究。通过哮喘控制问卷调查，比较了居住在CREON 2000A辐照系统家庭中的轻度至中度过敏性持续性哮喘儿童与居住在假单位家庭中的儿童的哮喘控制改善。该试验的次要终点是：早晨呼气峰流速，吸入总次数减少， 急救药物，哮喘恶化，缺课或工作。该试验包括一个探索性目的，旨在研究CREON 2000A的作用机制是否与紫外线照射导致室内过敏原的过敏原性降低的蛋白质结构变化有关。一个由经验丰富的大学和小企业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，已被召集来研究这种潜在的重要哮喘控制干预措施。目前的哮喘管理方法非常昂贵。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，实施多方面环境控制干预措施的每名儿童的年度费用在750美元至1 000美元之间，与哮喘药物的年度费用相当。改变父母行为的必要性，使他们保持耗时且往往昂贵的干预措施，为遵守这些建议造成了重大障碍。CREON 2000A设备需要最少的维护（即，每年更换一次灯泡和小过滤器），而且由于使用简单，家庭居住者不必改变他们的日常生活。因此，这种干预的可接受性和患者依从性非常好。包括CREON 2000A装置在10年内的摊销在内，这一干预措施的预计年度费用为244美元。因此，该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疾病相关的成本。

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.