MONTELUKAST OR AZITHROMYCIN FOR REDUCTION OF INHALED CORTICOSTEROIDS IN CHILD

孟鲁司特或阿奇霉素用于减少儿童吸入皮质类固醇

• 批准号: 7603404
• 负责人: Robert Strunk
• 金额: $ 3.75万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603404
• 关键词: Adrenal Cortex Hormones; Adverse effects; Agonist; Albuterol; Anti-Bacterial Agents; Anti-Inflammatory Agents; Anti-inflammatory; Asthma; Azithromycin; Breathing; Child; Chronic; Class; Clinical; Computer Retrieval of Information on Scientific Projects Database; Count; Cystic Fibrosis; Dose; Effectiveness; Funding; Grant; Institution; Leukotriene Antagonists; Macrolides; Outcome; Patients; Pharmaceutical Preparations; Placebos; Property; Pulmonary Function Test/Forced Expiratory Volume 1; Randomized; Research; Research Design; Research Personnel; Resources; Risk; Source; Steroids; Symptoms; Time; United States National Institutes of Health; Visit; Week; airway inflammation; day; design; eosinophil; improved; montelukast; pulmonary function

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.

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。 持续性哮喘患者有ICS副作用的高风险，这鼓励临床医生寻找方法来减轻患者的类固醇负担。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)在此类患者中的类固醇节省效果。 由于囊性纤维化的研究证明了这些药物的抗炎活性，而不仅仅是它们的抗菌特性，因此已建议将Mac用于治疗严重哮喘。另一类可能具有节省类固醇作用的药物是白三烯受体拮抗剂(LTRA)，它改善了呼吸道炎症和肺功能的标记物，同时减少了β-激动剂的使用、病情恶化和血液嗜酸性粒细胞计数。 MARS设计用于研究210名儿童(每个临床中心42名)，采用平行研究设计，将阿奇霉素与安慰剂、孟鲁司特与安慰剂进行比较。随着ICS剂量的减少，决定ICS节省的主要结果变量是哮喘控制不充分的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两周的观察，或c)FEV1和lt；80%的最佳预随机值连续两次访问1-4天，或(2)哮喘恶化，确定为需要全身皮质类固醇。