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.

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。 我们将招募在过去一年内发生COPD急性加重或使用辅助供氧的中重度COPD患者。合格受试者将随机接受大环内酯类抗生素、阿奇霉素或安慰剂治疗一年。主要结局是确定每日服用阿奇霉素是否会降低COPD急性加重的频率或严重程度。在受试者接受分配的研究治疗期间，我们将每月通过电话或诊所访视对受试者进行随访，并在停止研究治疗后1个月进行诊所访视。我们还将在某些诊所访视和一个月随访诊所访视时采集血液，以确定长期大环内酯类药物治疗对特定血液制品的影响。