EFFECT OF CHRON MACROLIDE ADMIN ON FREQUENCY & SEVERITY OF COPD EXACERBATIONS

大环内酯给药对频率的影响

• 批准号: 7603819
• 负责人: Fernando J Martinez
• 金额: $ 3.01万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603819
• 关键词: Address; Affect; Azithromycin; Biological Markers; Blood; Cause of Death; Cessation of life; Chemicals; Chronic; Chronic Obstructive Airway Disease; Computer Retrieval of Information on Scientific Projects Database; Condition; Consent Forms; Death Rate; Diagnosis; Disease; Enrollment; Frequencies; Funding; Future; Genetic; Grant; Healthy People 2010; Hospitalization; Institution; Intervention; Life; Lung; Lung diseases; Macrolide Antibiotics; Macrolides; Michigan; Parents; Patient Care; Patients; Population; Protocols documentation; Rate; Reporting; Research; Research Personnel; Resources; Severities; Smoker; Smoking; Source; Symptoms; Time; United States; United States National Institutes of Health; United States Public Health Service; Universities; mortality; prevent; respiratory

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. Chronic obstructive pulmonary disease (COPD in short) is a disease of the lungs that affects many smokers. During the course of this chronic condition, some patients develop one or more COPD "exacerbations" (that is, a temporary worsening of lung symptoms that may require hospitalization and could be life-threatening). Currently, COPD affects from 12.4 to 24 million people in the United States and is the fourth leading cause of death. Worldwide, COPD is the sixth leading cause of death and is the only condition in the top 10 causes of death that has an increasing of new diagnosis and death rates. It is therefore important to find a treatment that could prevent COPD exacerbations,reduce the severity of the episodes, and the mortality of the patients this disease affects. This project addresses an objective stated in the U.S. Public Health Service report "Healthy People 2010: Reduce deaths from COPD from 119 per 1000 people to 60 per 1000 people by 2010" (Objective 24-10). If the intervention that we propose reduces the rate or severity of COPD exacerbations it would be expected to reduce the rate of deaths of these patients. The study is broken down into three separate protocols, the Macrolide (parent) Protocol, the Biomarker and Genetic substudies. All study protocols have been incorporated into one consent document. Subjects will be given the opportunity to continue to participate in the Macrolide and Biomarker study, should they decide not to participate in the Genetic substudy. The Macrolide (parent) Protocol specific aim is to determine if the administration of a macrolide antibiotic (specifically Azithromycin) for one year will decrease the rate and the severity of COPD exacerbations when added to the usual care of these patients. The Biomarker Substudy: specific aims are to determine how certain biomarkers (chemicals) in the blood are related to respiratory conditions. The Genetic Substudy: specific aims of the genetic substudy are to collect blood from this patient population for future studies of smoking related diseases, including chronic obstructive pulmonary disease. The study is funded by the National Institutes of Health and is conducted by Dr. Martinez at the University of Michigan and researchers from nine other research institutions in the United States. We plan to enroll about 110 patients at the University of Michigan and over 1,100 patients nationally over a three year period of time.'

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 慢性阻塞性肺疾病（简称COPD）是一种影响许多吸烟者的肺部疾病。在这种慢性病的过程中，一些患者会出现一种或多种慢性阻塞性肺病“恶化”（即肺部症状暂时恶化，可能需要住院治疗并可能危及生命）。目前，慢性阻塞性肺病影响着美国 12.4 至 2400 万人，是第四大死因。在全球范围内，慢性阻塞性肺病是第六大死因，也是十大死因中唯一新诊断和死亡率不断增加的疾病。因此，找到一种可以预防 COPD 恶化、降低发作严重程度以及该疾病影响的患者死亡率的治疗方法非常重要。 该项目旨在实现美国公共卫生服务报告“2010 年健康人口：到 2010 年将 COPD 死亡人数从每 1000 人 119 人减少到每 1000 人 60 人”（目标 24-10）中提出的目标。如果我们提出的干预措施降低了慢性阻塞性肺病恶化的发生率或严重程度，则有望降低这些患者的死亡率。 该研究分为三个独立的方案：大环内酯（母体）方案、生物标志物和遗传子研究。所有研究方案均已纳入一份同意文件中。如果受试者决定不参加遗传亚研究，他们将有机会继续参加大环内酯和生物标志物研究。 大环内酯类（母体）方案的具体目的是确定在这些患者的常规护理中添加大环内酯类抗生素（特别是阿奇霉素）一年后是否会降低 COPD 恶化的发生率和严重程度。 生物标志物子研究：具体目标是确定血液中的某些生物标志物（化学物质）与呼吸系统疾病的关系。 基因亚组研究：基因亚组研究的具体目的是从该患者群体中收集血液，用于未来研究吸烟相关疾病，包括慢性阻塞性肺病。 该研究由美国国立卫生研究院资助，由密歇根大学的马丁内斯博士和来自美国其他九个研究机构的研究人员进行。我们计划在三年内招募密歇根大学约 110 名患者以及全国 1,100 多名患者。”