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; 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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 持续性哮喘患者对IC的副作用有很高的风险，鼓励临床医生寻求减轻患者类固醇负担的方法。 在这里，我们研究了这种患者的两种药物，一种大环内酯类（MAC）和白三烯受体拮抗剂（LTRA）的类固醇保留效果。 已经建议使用MAC作为严重哮喘的治疗，作为囊性纤维化研究的研究表明，药物的抗炎活性，而不是仅仅是其抗菌特性。 另一个具有类固醇保留作用的药物类是白三烯受体拮抗剂（LTRA），它改善了气道炎症和肺功能的两个标记，同时减少了β激动剂的使用，恶化和血液嗜酸性粒细胞计数。 MARS旨在在平行研究设计中研究210名儿童（每个临床中心42名），将阿奇霉素与安慰剂和蒙特鲁克斯特（Montelukast）与安慰剂进行了比较。 确定ICS的主要结果变量是将哮喘控制不足的标准重新出现，因为ICS的剂量减少了。 哮喘控制不足的定义是（1）慢性控制：（a）症状，或用于症状或低峰值流量或峰值流量的使用，或平均每周> 3天的峰值流量<80％的基线，或b）nictural症状觉醒，用于哮喘症状，需要在2周或CONS consitive of Consect of Consect of Consect of Vervect of Vervect of Vervect或C）fev1 <80％<80％<80％<80％）相隔1-4天或（2）由全身性皮质类固醇确定的哮喘加重。