Comparative effectiveness of environmental intervention and standard care in abil

描述(申请人提供)：DiMango，Emily/Kitan，Meyer在本申请中，我们提出了一项临床研究试验，以比较非药物治疗和标准药物治疗在哮喘中的作用。目标人群包括居住在曼哈顿、布朗克斯和纽约市地区的市中心少数族裔。该方案旨在确定旨在减少哮喘患者对室内过敏原的暴露的多方面环境干预在减少NAEPP阶梯疗法方面是否比常规护理更有效，NAEPP阶梯疗法是一种新的但重要的结果衡量标准。纽约曼哈顿的哥伦比亚大学医学中心和纽约布朗克斯的雅各比医院的合作将确保少数族裔个人在这项重要的研究中得到代表。该议定书涉及哮喘的一个主要公共卫生问题，这对整个哮喘人群来说是至关重要的，但对市中心的居民来说最为突出。这项拟议的研究严格测试了哮喘护理的国家指南，并填补了在理解环境补救的重要性方面的空白，因为它与控制哮喘的药物治疗的必要性进行了比较。研究结果可能会影响公共卫生政策以及第三方医疗保险公司的报销。这项申请的研究人员已被证明有能力设计和执行哮喘的临床研究试验，并有超出招聘预期的记录。具体地说，我们的研究旨在：i.)在48周的研究期间，通过对过敏原敏感型哮喘患者进行随机对照试验，确定旨在减少室内过敏原和刺激物暴露的环境干预在减少NAEPP分级治疗方面是否比常规护理更有效，ii)确定环境干预是否导致室内过敏原水平、过敏原特异性血清IgE水平、呼吸道高反应性、一氧化氮排泄分数、痰嗜酸细胞计数、哮喘症状评分、哮喘加重，在为期48周的研究期间，与常规护理相比，治疗失败和肺功能改善，以及iii)确定在随机接受环境干预的受试者中，与常规护理相比，特定过敏原IgE水平的降低与哮喘控制所需NAEPP步骤水平的降低之间是否存在关联。PHS 398/2590(11/07版)页面续格式页面 公共卫生相关性：DiMango、Emily/Kitan、Meyer在家庭中接触变应原是哮喘的一个主要公共卫生问题，对整个哮喘人群至关重要，但对市中心的居民最为突出。这项拟议的研究严格测试了哮喘护理的国家指南，并填补了在理解环境补救的重要性方面的空白，因为它与控制哮喘的药物治疗的必要性进行了比较。研究结果可能会影响公共卫生政策以及第三方医疗保险公司的报销。PHS 398/2590(11/07版)页面续格式页面

DESCRIPTION (provided by applicant): DiMango, Emily/Kattan, Meyer In this application, we propose a clinical research trial to compare non-pharmacologic therapy and standard pharmacologic therapy in asthma. The target population includes inner-city minority individuals living in Manhattan, the Bronx and the New York City area. This protocol is designed to determine whether multi- faceted environmental intervention aimed at reducing exposure to indoor allergens to which asthmatic patients are sensitized is more effective than usual care in reducing NAEPP step based therapy, a novel, but important outcome measure. Collaboration of Columbia University Medical Center in Manhattan, New York and Jacobi Hospital in the Bronx, New York will ensure that minority individuals are represented in this important study. The protocol involves a major public health concern in asthma, one that is critical for the entire asthma population, but is most salient for residents of inner cities. The proposed study rigorously tests national guidelines in asthma care and fills a gap in understanding the importance of environmental remediation as it compares with need for pharmacological therapy for asthma control. Results of the study have the potential to affect public health policy as well as reimbursement from third party health care insurance companies. Investigators in this application have the proven ability to design and execute clinical research trials in asthma, with a track record that exceed expectations for recruitment. Specifically, our study aims to: i.) determine via a randomized, controlled trial in allergen-sensitized asthmatic patients whether environmental intervention aimed at reducing exposure to indoor allergens and irritants is more effective in reducing NAEPP step based therapy than usual care over a 48 week study period, ii) determine if environmental intervention leads to reduction in indoor allergen levels, allergen- specific serum IgE levels, airway hyperresponsiveness, fractional excretion of nitric oxide, sputum eosinophil count, asthma symptom score, asthma exacerbations, treatment failures and improved lung function compared to usual care over a 48 week study period and iii) determine if there is an association between reduction in allergen specific IgE level and reduction in NAEPP step level required for asthma control among subjects randomized to environmental intervention compared with usual care. PHS 398/2590 (Rev. 11/07) Page Continuation Format Page PUBLIC HEALTH RELEVANCE: DiMango, Emily/Kattan, Meyer Exposure to allergens within the household is a major public health concern in asthma, one that is critical for the entire asthma population, but is most salient for residents of inner cities. The proposed study rigorously tests national guidelines in asthma care and fills a gap in understanding the importance of environmental remediation as it compares with need for pharmacological therapy for asthma control. Results of the study have the potential to affect public health policy as well as reimbursement from third party health care insurance companies. PHS 398/2590 (Rev. 11/07) Page Continuation Format Page