CLINICAL TRIAL: EFFECT OF CHRONIC MACROLIDE ADMINISTRATION ON COPD EXACERBATIONS

临床试验：长期服用大环内酯对 COPD 恶化的影响

• 批准号: 7951154
• 负责人: STEVEN M SCHARF
• 金额: $ 16.02万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951154
• 关键词: Azithromycin; Blood; Chronic; Chronic Obstructive Airway Disease; Clinic Visits; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Frequencies; Funding; Grant; Institution; Macrolide Antibiotics; Macrolides; Oxygen; Patients; Placebos; Randomized; Recruitment Activity; Research; Research Personnel; Resources; Severities; Source; Telephone; United States National Institutes of Health; blood product; follow-up; primary outcome

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. We will recruit patients with moderate to severe COPD who have either had a COPD exacerbation within the past year or who use supplemental oxygen. Eligible subjects will be randomized to receive either a macrolide antibiotic, azithromycin, or placebo for one year. The primary outcome will be to determine whether or not taking azithromycin daily will decrease the frequency or severity of COPD exacerbations. We will follow subjects monthly, either by phone or by clinic visit, while they receive their assigned study treatment and at a clinic visit one month after they stop the study treatment. We will also collect blood at certain clinic visits and the one-month follow-up clinic visit to determine the effect of chronic macrolide treatment on specific blood products.

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。 我们将招募患有中度至重度COPD的患者，他们要么在过去一年内发生COPD加重或使用补充氧气。合格的受试者将被随机地接受一年的大环内酯类抗生素，阿奇霉素或安慰剂。主要结果是确定每天服用阿奇霉素是否会降低COPD加重的频率或严重性。我们将每月通过电话或诊所访问接受受试者，同时他们在停止学习治疗后的一个月后接受分配的学习治疗。我们还将在某些诊所就诊和一个月的随访诊所就诊中收集血液，以确定慢性大花环治疗对特定血液产品的影响。