MARS

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 主要假设：在中重度持续性哮喘儿童中，与安慰剂相比，大环内酯类（Mac）或白三烯受体拮抗剂（LTRA）将提供类固醇节省效应，因为吸入性皮质类固醇（ICS）的剂量减少。将在中至高剂量ICS联合长效β受体激动剂（LABA）控制症状后进行检测。这些ICS剂量的使用将基于NHLBI逐步增加指南，以实现哮喘控制。确定ICS保留的主要结局变量将是随着ICS剂量的降低，哮喘控制不充分标准重现的时间。哮喘控制不充分定义为（1）慢性控制不良：（a）症状，或使用沙丁胺醇治疗症状或低峰流量，或峰流量<80% baseline on >平均每周3天，或B）在2周的观察期内因哮喘症状需要沙丁胺醇治疗2个或更多个晚上的夜间觉醒，或c）在间隔1-4天的2次连续访视中，FEV 1 &lt;随机化值的80%（2）哮喘急性发作，根据对全身皮质类固醇的需求确定。

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.