CLINICAL TRIAL: ANTI-LEUKOTRIENE THERAPY FOR COPD EXACERBATIONS

临床试验：抗白三烯疗法治疗慢性阻塞性肺病恶化

基本信息

批准号：
7951176
负责人：
STEVEN M SCHARF
金额：
$ 1.14万
依托单位：
UNIVERSITY OF MARYLAND BALTIMORE
依托单位国家：
美国
项目类别：
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/7951176
关键词：
Accounting Acute Adrenal Cortex Hormones Antibiotics Arachidonate 5-Lipoxygenase Asthma Bronchodilator Agents Caring Cessation of life Charge Chronic Obstructive Airway Disease Clinical Research Clinical Trials Computer Retrieval of Information on Scientific Projects Database Cost Savings Data Drops Funding Grant Health Care Costs Hospitalization Hospitals Inflammation Mediators Inpatients Institution Length of Stay Leukotriene B4 Leukotriene E4 Leukotrienes Lipoxygenase Inhibitors Morbidity - disease rate Motivation Oral Patients Plasma Play Pulmonary Function Test/Forced Expiratory Volume 1 Research Research Personnel Resources Risk Factors Role Severities Source Sputum United States Agency for Healthcare Research and Quality United States National Institutes of Health Zileuton base mortality neutrophil novel therapeutic intervention prednisolone safety testing treatment as usual

项目摘要

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. Exacerbations of chronic obstructive pulmonary disease impose a considerable burden with regard to morbidity, mortality, and health care cost. In the year 2000, COPD exacerbations were responsible for 726,000 hospitalizations, and 119,000 deaths in the US. Based on data from the Agency for Healthcare Research and Quality, patients admitted to US hospitals for COPD in 2002 had a mean length of stay of 5.1 days and accounted for $15,400 in charges. Current management of COPD exacerbations includes bronchodilators, corticosteroids, and antibiotics. Because leukotrienes may play an important role in COPD exacerbations, we propose to study whether anti-leukotriene therapy provides additional benefit to usual care in the management of COPD exacerbations requiring inpatient care. The rationale for anti-leukotriene therapy in acute exacerbations of COPD is based on studies of mediators of inflammation in COPD, on clinical trials of anti-leukotriene therapy in COPD, and on a clinical trial of anti-leukotriene therapy in exacerbations of asthma. The motivation for identification of a novel therapeutic approach to COPD exacerbations is that a reduction in hospital length of stay should result in significant cost savings in the management of this common condition. Clinical studies of the role of leukotrienes in COPD exacerbations indicate that leukotriene levels are elevated in acute exacerbations of COPD, that these elevations are associated with the severity of exacerbation, that levels drop with treatment of the exacerbation and that leukotriene B4 (LTB4)contributes significantly to the neutrophil chemotactic activity of sputum. Shindo et al. demonstrated that mean plasma leukotriene E4 (LTE4) levels in patients with COPD are elevated during acute exacerbation before treatment. They also found that LTE4 levels correlated with PaO2 and FEV1 in patients during acute exacerbation before prednisolone treatment, suggesting that elevated LTE4 levels are a risk factor for more severe exacerbations. The purpose of this study is to test the safety and efficacy of oral zileuton (a 5-lipoxygenase inhibitor) in addition to usual care for treatment of acute exacerbations of COPD requiring inpatient care.

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。慢性阻塞性肺部疾病的加剧对发病率，死亡率和医疗保健费用造成了重大负担。在2000年，COPD加剧造成726,000次住院和119,000人死亡。根据医疗保健研究和质量机构的数据，2002年在美国医院接受COPD的患者的平均停留时间为5.1天，收费$ 15,400。 COPD加重的当前管理包括支气管扩张剂，皮质类固醇和抗生素。由于白细胞可能在COPD加剧中发挥重要作用，因此我们建议研究抗Leukotriene疗法是否在COPD加剧需要住院治疗的COPD管理方面是否为常规护理提供了额外的好处。 COPD急性加重抗白细胞治疗的基本原理是基于COPD中炎症介质的研究，COPD中抗白细胞疗法的临床试验以及对抗病患病患者的抗链苯二甲酸酯治疗的临床试验。确定一种新型治疗方法的动机COPD加剧方法是，住院时间的降低应减少，在这种常见状况的管理中应大量节省成本。白细胞中白细胞在COPD加剧中的作用的临床研究表明，在COPD的急性加重中，白三烯水平升高，这些升高与恶化的严重程度有关，这些水平随着病情的处理而下降，而白细胞B4（LTB4）的活性显着贡献了中等性的化学作用。 Shindo等。证明在治疗前急性加重期间，COPD患者的平均血浆白细胞E4（LTE4）水平升高。他们还发现，在泼尼松龙治疗前急性加重期间，患者的LTE4水平与PAO2和FEV1相关，这表明LTE4水平升高是更严重加重的危险因素。这项研究的目的是测试口服Zileuton（一种5-脂氧合酶抑制剂）的安全性和功效，除了治疗需要住院治疗的COPD急性加重的急性加重。