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: 7952239
• 负责人: RICHARD CASABURI
• 金额: $ 16.66万
• 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: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952239
• 关键词: Adverse effects; Anti-Inflammatory Agents; Anti-inflammatory; Antibiotics; Azithromycin; Bulla; Cessation of life; Chronic; Chronic Obstructive Airway Disease; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Computers; Cystic Fibrosis; Double-Blind Method; Evaluation; Frequencies; Funding; Grant; Health Expenditures; Health Status; Hospitalization; Hour; Institution; Intervention; 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; Telephone; United States National Institutes of Health; Visit; 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. Participants will come to the study center on 8 occasions (for roughly 3 hours/visit): two in the initial evaluation period, at months 1, 3, 6, 9 and 12 of the intervention and one month following the end of the intervention. Patients will also receive phone calls to ascertain their health status periodically during the intervention and for the two years (every 6 months) after the intervention ends.

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。 这项研究旨在找到一种方法来降低COPD急性加重的频率和严重程度，这种疾病通常导致住院和死亡，并且是COPD医疗保健支出的最大组成部分。 以前的研究表明，各种抗生素，大环内酯类，长期使用，可以减少支气管扩张和囊性纤维化（另外两种肺部疾病）的恶化。 是这项研究吗？本研究的目的是观察长期服用大环内酯类抗生素阿奇霉素（齐舒美）是否会减少COPD急性加重;如果存在，本研究有能力检测到20%的减少。 选择阿奇霉素是因为它具有良好的副作用，抗炎和抗生素作用，而且它很快就会关闭专利，并且（如果研究成功）将为COPD治疗提供相对低成本的增强 该网络将招募1130例COPD和急性加重高风险（以既往急性加重或长期补充供氧为标志）患者（该研究中心约113例）进行为期一年的试验。 受试者将以双盲方式随机接受阿奇霉素每日250 mg或外观相同的安慰剂。 这种药物将被分配在一个高科技的泡罩包装卡;一个计算机芯片嵌入在泡罩包装将允许跟踪时，每天服用的药物。 受试者将在8个场合（约3小时/次访视）前往研究中心：两次在初始评估期，干预的第1、3、6、9和12个月以及干预结束后1个月。 在干预期间和干预结束后的两年（每6个月）内，患者还将定期接受电话咨询，以确定其健康状况。