Environmental Control as Add-on Therapy in Urban Children with Asthma

环境控制作为城市哮喘儿童的附加治疗

• 批准号: 8791315
• 负责人: Elizabeth C. Matsui
• 金额: $ 67.39万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-13 至 2018-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8791315
• 关键词: Address; Adrenal Cortex Hormones; Allergens; Allergic; Allergic inflammation; Asthma; Biological Markers; Breathing; Canis familiaris; Child; Dictyoptera; Dose; Environmental Exposure; Felis catus; Guidelines; Health; Home environment; IgE; Indoor pollutant; Inflammatory; Influentials; Intervention; Intervention Trial; Link; Measures; Mediating; Morbidity - disease rate; Mus; Outcome; Participant; Particulate Matter; Pathway interactions; Pharmaceutical Preparations; Policies; Randomized Controlled Trials; Role; Serum; Skin Test End-Point Titration; Stratification; Symptoms; Testing; Third-Party Payer; Titrations; Treatment Step; arm; asthmatic; base; clinical effect; cost; design; disease natural history; environmental intervention; eosinophil; improved; indoor allergen; inner city; mast cell; novel; peripheral blood; pollutant; pyroglyphid

DESCRIPTION (provided by applicant): High indoor allergen and pollutant levels have repeatedly been linked to asthma morbidity, especially among urban children, who have among the highest asthma morbidity in the US. However, environmental intervention trials for asthma have typically compared an environmental control strategy (ECS) to no intervention, a design that does not reflect the recommended approach to asthma management, which includes ECSs in conjunction with titration of controller medication. As a result, it remains unknown whether the addition of an ECS to controller medication titration results in improved asthma control, and therefore a reduced controller medication requirement. Another unanswered question is whether the addition of an ECS to controller medication titration results in greater reduction of allergic inflammation than medication titration alone. ECSs may have a greater effect on allergic inflammation than controller medications because ECSs target the most upstream point of the asthma inflammatory pathway by reducing pro-inflammatory environmental exposures, while controller medications target a downstream point of this pathway. Surprisingly, it is also unknown whether the improvement in asthma in ECS trials is mediated by reductions in allergen levels and/or reduction in pollutant levels. Understanding the factors that mediate the effects of an ECS on asthma is important for refuting, or supporting, a causal role for indoor allergens and/or pollutants in asthma morbidity, and also for optimizing the design of ECSs to target the most influential factors. We therefore hypothesize that the addition of an individually-tailored, multi-faceted ECS to guidelines-based controller medication titration will result in less controlle medication requirement and allergic inflammation than controller medication titration alone among urban asthmatic children. We will test this hypothesis and identify the factors that mediate the clinical effects of the ECS with a parallel-arm, randomized controlled trial of ECS plus controller medication titration vs. controller medication titration alone. Our aims are: (1) T determine the effect of the addition of ECS to controller medication titration on controller medication requirements and allergic inflammatory biomarkers, and (2) To determine whether reductions in particulate matter (PM) and/or indoor allergens mediate the effects of an ECS on asthma. This proposed trial will answer a pivotal question because if ECSs do not provide additional benefit in the context of treatment with controller medication, the role of ECS in asthma management should be downgraded. On the other hand, if ECSs do indeed reduce controller medication requirements, greater emphasis should be placed on the importance of ECSs in asthma management, studies should be conducted to identify best ECS practices, and policies should be changed to require third party payers to cover ECS costs.

描述（由申请人提供）：高室内过敏原和污染物水平反复与哮喘发病率有关，尤其是在美国哮喘发病率最高的城市儿童中。但是，哮喘的环境干预试验通常将环境控制策略（EC）与无干预进行了比较，这种设计不反映推荐的哮喘管理方法，其中包括ECSS与控制器药物的滴定结合使用。结果，仍然未知是否 在控制器药物滴定中添加ECS可改善哮喘控制，因此减少了控制器药物的要求。另一个未解决的问题是，在控制器药物滴定中添加EC是否会导致过敏性炎症的减少比单独的药物滴定更大。 ECS可能会对过敏性炎症具有更大的影响，因为ECSS通过减少促炎性环境暴露而定位的哮喘炎症途径上游点最上游点，而控制器药物的目标是该途径的下游点。令人惊讶的是，尚不清楚ECS试验中哮喘的改善是否是通过过敏原水平降低和/或污染物水平降低来介导的。了解介导ECS对哮喘的影响的因素对于驳斥或支持室内过敏原和/或污染物在哮喘发病率中的因果作用很重要，也可用于优化ECS的设计以靶向最具影响力的因素。因此，我们假设在基于指南的控制器药物滴定中添加单独计量的多方面EC将导致与单独的Controler药物滴定相比，仅在Urban Astthmatic儿童中，将导致减少控制剂药物的需求和过敏性炎症。我们将检验这一假设，并确定通过ECS和控制器药物滴定与控制器药物滴定的平行臂，随机对照试验的介导EC临床效应的因素。我们的目的是：（1）t确定将EC添加到控制器药物滴定对控制器药物需求和过敏性炎症生物标志物中的影响，以及（2）确定颗粒物（PM）和/或室内过敏原的减少是否减少ECS对哮喘的影响。该提议的试验将回答一个关键的问题，因为如果ECS在用控制器药物治疗的背景下没有提供额外的好处，则应降级ECS在哮喘管理中的作用。另一方面，如果ECS确实确实减少了控制器药物的要求，则应更加重视ECS在哮喘管理中的重要性，应进行研究以确定最佳ECS实践，并应更改政策以要求第三方付款人以支付ECS费用。