MONTELUKAST OR AZITHROMYCIN FOR REDUCTION OF INHALED CORTICOSTEROIDS IN CHILD

这个子项目是许多研究子项目中的一个 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。 持续性哮喘患者有ICS副作用的高风险，鼓励临床医生寻求减少患者类固醇负担的方法。 在这里，我们研究了两种药物，大环内酯类（Mac）和白三烯受体拮抗剂（LTRA）在这类患者中的类固醇保留效果。 已建议使用Mac作为严重哮喘的治疗方法，因为囊性纤维化的研究证明了药物的抗炎活性，而不仅仅是其抗菌特性。 另一类可能具有类固醇节省作用的药物是白三烯受体拮抗剂（LTRA），它改善了气道炎症和肺功能的标志物，同时减少了β受体激动剂的使用，加重和血液嗜酸性粒细胞计数。 MARS旨在以平行研究设计研究210名儿童（每个临床中心42名），比较阿奇霉素与安慰剂和孟鲁司特与安慰剂。 确定ICS保留的主要结局变量是随着ICS剂量的降低，至再次出现哮喘控制不佳标准的时间。 哮喘控制不充分定义为（1）慢性控制不佳：（a）症状，或使用沙丁胺醇治疗症状或低峰流量，或<80% baseline on >平均每周3天出现峰流量，或B）在2周的观察期内因哮喘症状需要沙丁胺醇治疗2晚或2晚以上的夜间觉醒，或c）在间隔1-4天的2次连续访视中，FEV 1 &lt;最佳随机化前值的80%，或（2）根据对全身性皮质类固醇的需求确定哮喘急性发作。

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. Patients with persistent asthma are at high risk for side effects from the ICS, encouraging clinicians to seek ways to reduce the steroid burden in their patients. Here we study the steroid sparing effectiveness of two medications, a macrolide (Mac) and a leukotriene receptor antagonist (LTRA) in such patients. Use of Mac has been suggested as treatment for severe asthma as studies in cystic fibrosis demonstrated anti-inflammatory activities of the drugs rather than simply their anti-bacterial properties. Another drug class with possible steroid sparing effects is leukotriene receptor antagonist (LTRA), which improved both markers of airway inflammation and pulmonary function, while reducing beta agonist use, exacerbations, and blood eosinophil counts. MARS is designed to study 210 children (42 per clinical center) in a parallel study design, comparing azithromycin to placebo and montelukast to placebo. The primary outcome variable to determine ICS sparing is 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 best pre-randomization value on 2 consecutive visits 1-4 days apart or (2) an asthma exacerbation as determined by need for systemic corticosteroids.