Mouse Allergen and Asthma Intervention Trial

描述（由申请人提供）：哮喘是最常见的慢性疾病之一，它不成比例地影响居住在城市地区的弱势群体。由于多种原因，小鼠过敏原暴露似乎在城市哮喘流行中发挥着关键作用。(1)小鼠m1是主要的小鼠过敏原，在95%的市中心家庭中发现，市中心家庭的浓度比郊区家庭高100倍。(2)多达25-50%的哮喘儿童生活在城市地区，有证据表明IgE对小鼠过敏，使他们容易受到小鼠过敏原引发的哮喘症状。(3)在IgE致敏的哮喘儿童中，家庭小鼠过敏原暴露与更多的症状天数、更多的急救药物使用和更多的哮喘相关医疗保健使用相关，与蟑螂致敏和暴露状态无关。由于这些原因，针对降低家庭Mus m 1水平的环境干预是降低城市人群哮喘发病率的一种有前途的方法。初步证据表明，小鼠过敏原靶向的环境干预（MA-EI）是有效的，在减少小鼠的m 1水平提供了最后一块的背景数据，以支持这一假设，即MA-EI将减少哮喘发病率在小鼠致敏的个人与哮喘。为了验证这一假设，我们建议进行一项多中心，随机临床试验的MA-EI在三个主要的城市中心与高患病率的哮喘和小鼠致敏性，高家庭小鼠的m 1水平。具体目标是：（1）评价小鼠过敏原靶向EI在减少城市地区小鼠致敏哮喘儿童和年轻成人Mus m 1暴露方面的有效性;（2）评价减少小鼠过敏原暴露在降低哮喘发病率方面的有效性。我们将评估症状天数作为主要结局变量，急救药物使用、哮喘相关医疗保健使用、呼出的一氧化氮水平和肺功能作为次要结局变量。对于本临床试验的计划阶段，我们提出了以下目标：（1）最终确定研究方案，制定程序手册和数据安全性监测计划，并完成IRB批准流程，（2）制定数据管理计划，以及（3）建立社区咨询委员会。临床试验的结果将为家庭小鼠过敏原暴露对城市哮喘人群的影响提供重要见解，并直接为公共卫生策略提供信息，以减少市中心哮喘负担。

DESCRIPTION (provided by applicant): Asthma is one of the most common chronic illnesses and it disproportionately affects disadvantaged populations residing in urban areas. Mouse allergen exposure, in particular, appears to play a critical role in the urban asthma epidemic for several reasons. (1) Mus m 1, the major mouse allergen, is found in 95% of inner-city homes, and is found in 100-fold higher concentrations in inner-city homes than in suburban homes. (2) As many as 25-50% of children with asthma living in urban areas have evidence of IgE-sensitization to mouse, making them susceptible to mouse allergen-triggered asthma symptoms. (3) Household mouse allergen exposure is associated with more symptoms days, more rescue medication use, and more asthma-related health care use among IgE-sensitized children with asthma, independent of cockroach sensitization and exposure status. For these reasons, an environmental intervention targeted at reducing household Mus m 1 levels is a promising approach to reducing asthma morbidity in urban populations. Preliminary evidence indicating that a mouse allergen-targeted environmental intervention (MA-EI) is efficacious in reducing Mus m 1 levels provides the final piece of background data to support the hypothesis that a MA-EI will reduce asthma morbidity in mouse-sensitized individuals with asthma. To test this hypothesis, we propose conducting a multi-center, randomized clinical trial of MA-EI at three major urban centers with high prevalence rates of asthma and mouse sensitization, and high household Mus m 1 levels. The specific aims are: (1) To evaluate the efficacy of a mouse allergen-targeted EI in reducing Mus m 1 exposure in mouse-sensitized children and young adults with asthma living in urban areas, and (2) To evaluate the efficacy of reduction of mouse allergen exposure in reducing asthma morbidity. We will assess symptom days as the primary outcome variable, in addition to rescue medication use, asthma-related health care use, exhaled nitric oxide levels and pulmonary function as secondary outcome variables. For the planning phase of this clinical trial, we propose the following aims: (1) Finalization of the study protocol, development of the manual of procedures and the data safety monitoring plan, and completion of the IRB approval process, (2) Development of the data management plan, and (3) Establishment of community advisory boards. The findings from the clinical trial will lend critical insight into the impact of household mouse allergen exposure on urban populations with asthma, and directly inform public health strategies to reduce the inner-city asthma burden.