THE EFFECT OF CHRONIC MACROLIDE ADMINISTRATION ON THE FREQUENCY AND SEVERITY OF

长期使用大环内酯类药物对发生频率和严重程度的影响

• 批准号: 8174482
• 负责人: RICHARD CASABURI
• 金额: $ 8.94万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8174482
• 关键词: Adverse effects; Anti-Inflammatory Agents; Anti-inflammatory; Antibiotics; Azithromycin; Bulla; Cessation of life; Chronic; Chronic Obstructive Airway Disease; Computer Retrieval of Information on Scientific Projects Database; Computers; Cystic Fibrosis; Double-Blind Method; Frequencies; Funding; Grant; Health Expenditures; Hospitalization; Institution; Lead; Legal patent; Lung diseases; Macrolide Antibiotics; Macrolides; Medicine; Oxygen; Participant; Patients; Pharmaceutical Preparations; Placebos; Randomized; Recruitment Activity; Research; Research Personnel; Resources; Severities; Site; Source; Technology; United States National Institutes of Health; cost; high risk

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. This study seeks to find a way to decrease frequency and severity of COPD exacerbations, illnesses that often lead to hospitalizations and death and are the largest component of COPD health care expenditures. Previous studies have shown that a variety of antibiotics, the macrolides, given chronically, reduce exacerbations in both bronchietasis and cystic fibrosis (two other lung diseases). It is this study?s purpose to see if chronic administration of the macrolide antibiotic Azithromycin (Zithromax) will reduce COPD exacerbations; the study is powered to detect a 20% reduction if one exists. Azithromycin was chosen because of its excellent side effect profile, its anti-inflammatory as well as antibiotic effects and because it will soon be off patent and will (if the study is successful) provide a relatively low-cost enhancement to COPD therapy The Network will recruit 1130 patients ( approximately 113 at this site) with COPD and a high risk of exacerbation (marked by previous exacerbation or chronic supplemental oxygen use) for a one-year trial. Participants will be randomized in a double-blind manner to either Azithromycin 250mg daily or an identically-appearing placebo. The drug will be dispensed in a high-technology blister pack card; a computer chip imbedded in the blister pack will allow tracking when the medicine is taken each day.

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。 这项研究试图找到一种方法来降低COPD恶化的频率和严重程度，COPD恶化是COPD医疗保健支出的最大组成部分，这种疾病经常导致住院和死亡。以前的研究表明，长期服用各种抗生素和大环内酯类药物，可以减少支气管炎和囊性纤维化(另外两种肺部疾病)的恶化。这就是这项研究吗？S的目的是看看长期服用大环内酯类抗生素阿奇霉素(Zithromax)是否会减少慢性阻塞性肺疾病的恶化；这项研究的目的是检测到如果存在的话，可以减少20%。选择阿奇霉素是因为其良好的副作用、抗炎和抗生素作用，而且因为它很快就会失去专利，并且(如果研究成功)将为COPD治疗提供相对较低的成本改进 该网络将招募1130名慢性阻塞性肺病(COPD)患者(在本网站约113名)和高恶化风险(以既往恶化或长期补充氧气为标志)进行为期一年的试验。参与者将以双盲方式随机服用阿奇霉素250 mg/d或外观相同的安慰剂。这种药物将被分配在高科技泡罩包装卡中；嵌入泡罩包装中的计算机芯片将允许跟踪每天服用药物的时间。