INNER CITY ANTI IGE THERAPY FOR ASTHMA-MECHANISTIC STUDY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 ACE是一项随机、前瞻性、平行组试验。ACE方案的目的是确定与不使用生物标记物的国家哮喘教育和预防计划(NAEPP)指南方法相比，补充生物标记物的哮喘治疗方法是否可以改善哮喘结果。在该方案中评估的生物标记物将是呼出的一氧化氮(ENO)。主要的结果衡量标准将是在3周的磨合期和46周的治疗策略期(49周研究期)内测量的有哮喘症状和哮喘加重的天数。 在这项试验中，将研究500名患有持续性哮喘的市中心参与者，年龄在12-20岁之间。他们将从美国十个主要城市地区招募，其中包括西奈山医疗中心的50名患者。 这项研究将包括筛查访问(访问1)后的3周磨合期和随机化访问(访问2)后的46周治疗期，在此期间，参与者被置于参考战略小组(仅限NAEPP指南)或Biomarker战略小组(根据NAEPP指南考虑ENO测量)。这两个治疗策略组的参与者都将按照NAEPP指南的方式，使用β-激动剂的救援算法和/或哮喘恶化的短期泼尼松进行支持和管理。哮喘药物治疗方案包括6个治疗水平，从低剂量的氟替卡松DPI(100微克，每天2次)开始，根据需要，以100微克/50微克的每日2次，250微克/50微克的每日2次，以及500微克/50微克的每日2次，根据需要使用小剂量茶碱或孟鲁司特。将使用双盲设计，以使参与者、研究医生、哮喘咨询师和参与者自己的(非研究)医生不知道治疗策略分配。研究协调员没有被蒙在鼓里。 假设： 除了现有NAEPP指南(参考策略)中的建议外，旨在减少eNO(生物标记物策略)的治疗策略将导致更有效的哮喘控制，这取决于哮喘症状和恶化的减少。 将eNO(作为炎症的生物标记物)添加到护理标准(NIH指南)将减少哮喘症状和恶化。 对于那些高度致敏并暴露于室内过敏原的儿童来说，呼出的一氧化氮将是一种不太有效的治疗辅助手段。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. ACE is a randomized, prospective, parallel group trial. The objective of the ACE protocol is to determine whether a biomarker-supplemented approach to asthma therapy improves asthma outcomes as compared to a National Asthma Education and Prevention Program (NAEPP) guidelines-based approach without the use of this biomarker. The biomarker to be evaluated in this protocol will be exhaled nitric oxide (eNO). The primary outcome measures will be days with asthma symptoms and asthma exacerbations as measured over a run-in period of 3 weeks and a treatment strategy period of 46 weeks (49 week study period). Five hundred inner-city participants, ages 12-20 years, with persistent asthma will be studied in this trial. They will be enrolled from ten major urban areas in the United States, including fifty patients at Mount Sinai Medical Center. The study will consist of a 3-week run-in period following the Screening Visit (Visit 1) and a 46-week treatment period following the Randomization Visit (Visit 2) in which participants are placed in either the Reference Strategy Group (NAEPP guidelines alone) or the Biomarker Strategy Group (eNO measurements considered with NAEPP guidelines). Participants in both treatment strategy groups will be supported and managed with rescue algorithms of beta-agonists, and/or short courses of prednisone for asthma exacerbation in a manner consistent with NAEPP guidelines. The asthma medication regimen consists of six treatment levels, starting with low-dose Fluticasone DPI (100 mcg bid), and moving up to Advair¿ Diskus at 100 mcg/50 mcg bid, 250 mcg/50 mcg bid, and 500 mcg/50 mcg bid with either low dose theophylline or montelukast, as needed. A double-blind design will be used so that the treatment strategy assignment is unknown to the participant, study physician, asthma counselor, and the participant's own (non-study) physicians. The study coordinator is unblinded. Hypothesis: " A treatment strategy aimed at reducing eNO (biomarker strategy) in addition to the recommendations in the existing NAEPP guidelines (reference strategy) will lead to more effective asthma control, as determined by a reduction in asthma symptoms and exacerbations. " The addition of eNO (as a biomarker for inflammation) to standard of care (NIH Guidelines) will reduce asthma symptoms and exacerbations. " Exhaled nitric oxide will be a less effective treatment adjunct for those children highly sensitized and exposed to indoor allergens.