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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 持续性哮喘患者面临 ICS 副作用的高风险，这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（大环内酯类药物 (Mac) 和白三烯受体拮抗剂 (LTRA)）对此类患者的类固醇节约效果。 人们建议使用 Mac 来治疗严重哮喘，因为囊性纤维化研究证明了该药物的抗炎活性，而不仅仅是其抗菌特性。 另一种可能具有类固醇节约作用的药物是白三烯受体拮抗剂 (LTRA)，它可以改善气道炎症和肺功能的标志物，同时减少 β 激动剂的使用、病情加重和血液嗜酸性粒细胞计数。 MARS 旨在以平行研究设计对 210 名儿童（每个临床中心 42 名）进行研究，比较阿奇霉素与安慰剂、孟鲁司特与安慰剂。 确定 ICS 保留的主要结果变量是随着 ICS 剂量减少而再次出现哮喘控制不足标准的时间。 哮喘控制不充分的定义为 (1) 长期控制不佳：(a) 出现症状，或使用沙丁胺醇治疗症状或峰流量低，或平均每周超过 3 天峰流量 <80% 基线，或 b) 在 2 周的观察期间因哮喘症状而夜间醒来，需要 2 晚或以上的沙丁胺醇，或 c) FEV1 在连续 2 次就诊时<最佳随机化前值的 80% 间隔 1-4 天或 (2) 根据需要全身皮质类固醇确定的哮喘恶化。