MARS

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。 主要假设：在中到重度持续性哮喘的儿童中，与安慰剂相比，大环内酯(Mac)或白三烯受体拮抗剂(LTRA)将提供类固醇节省效应，因为吸入皮质类固醇(ICS)的剂量减少。这将在中到高剂量的ICS结合长效β-激动剂(LABA)控制症状后进行测试。这些ICS剂量的使用将基于NHLBI逐步指南，以实现哮喘控制。随着ICS剂量的减少，决定ICS节省的主要结果变量将是哮喘控制不充分标准重新出现的时间。哮喘控制不足的定义是：(1)慢性控制不良：(A)症状，或沙丁胺醇的使用症状或低峰值流量，或峰值流量和80%的基线平均每周三天，或b)夜间觉醒的哮喘症状，需要沙丁胺醇2个或更多的夜晚超过2周的观察，或c)FEV1&lt；80%的随机值连续两次访问，间隔1-4天(2)哮喘恶化，由需要全身皮质类固醇确定。

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. Principal hypothesis: In children with moderate to severe persistent asthma, a macrolide (Mac) or a leukotriene receptor antagonist (LTRA) will provide a steroid-sparing effect when compared to placebo as the dose of inhaled corticosteroid (ICS) is reduced. This will be tested following achievement of control of symptoms with moderate to high dose ICS in combination with a long acting beta agonist (LABA). Use of these ICS doses will be based on NHLBI step-up guidelines to achieve asthma control. The primary outcome variable to determine ICS sparing will be the time to reappearance of criteria of inadequate asthma control as the dose of ICS is reduced. Inadequate asthma control is defined as either (1) chronic poor control: (a) symptoms, or albuterol use for symptoms or low peak flow, or peak flow <80% baseline on >3 days per week on average, or b) nocturnal awakenings for asthma symptoms requiring albuterol 2 or more nights over 2 weeks of observation, or c) FEV1 <80% of the randomization value on 2 consecutive visits 1-4 days apart of (2) an asthma exacerbation as determined by need for systemic corticosteroids.