ANTI-LEUKOTRIENE THERAPY FOR COPD EXACERBATIONS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 美国国立卫生研究院已经建立了COPD临床研究网络，以寻求新的COPD疗法。COPD(慢性阻塞性肺疾病，又称慢性支气管炎和肺气肿)是一种慢性肺部疾病，通常由吸烟引起，是美国第四大死因。美国各地的十个大学中心组成了这个网络。 慢性阻塞性肺病(涉及肺部的严重疾病)的恶化在发病率、死亡率和医疗费用方面造成了相当大的负担。2000年，在美国，慢性阻塞性肺病的恶化导致72.6万人住院，11.9万人死亡。根据卫生保健研究和质量机构的数据，2002年美国医院收治的慢性阻塞性肺病患者平均住院时间为5.1天，费用为15,400美元。目前对COPD恶化的治疗包括支气管扩张剂、皮质类固醇和抗生素。由于白三烯(血液中参与炎症的物质)可能在COPD恶化中发挥重要作用，我们建议研究在需要住院治疗的COPD恶化的管理中，抗白三烯治疗是否在常规治疗的基础上提供额外的好处。抗白三烯治疗COPD急性加重期的理论基础是基于对COPD炎症介质的研究、COPD抗白三烯治疗的临床试验以及抗白三烯治疗哮喘急性加重期的临床试验。确定COPD恶化的新治疗方法的动机是，住院时间的缩短应该会在这种常见疾病的管理方面带来显着的成本节约。 我们建议进行一项平行分组、双盲、安慰剂对照的随机试验，比较齐留通(600毫克，每天4次口服)和安慰剂(一种非活性药片)14天疗程对需要住院治疗的慢性阻塞性肺疾病恶化的治疗效果。患者将在港湾-加州大学洛杉矶分校医学中心入院后12小时内参加这项研究。主要结果将是住院时间。将在18个月内招收约520名受试者(该中心约60名)。

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. The National Institutes of Health has established the COPD Clinical Research Network to seek new COPD therapies. COPD (chronic obstructive pulmonary disease, also called chronic bronchitis and emphysema) is a chronic lung disease usually caused by cigarette smoking and is the 4th leading cause of death in the United States. Ten University-based centers around the United States constitute the Network. Exacerbations of chronic obstructive pulmonary disease (serious illnesses involving the lungs) 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 (substances in the blood involved in inflammation) 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. We propose a parallel group, double blind, placebo-controlled randomized trial of the effects of a 14 day course of zileuton (600mg given orally 4 times a day) in addition to usual care vs placebo (an inactive pill) in addition to usual care in the management of COPD exacerbations requiring inpatient care. Patients will be enrolled in the study within 12 hours of admission to Harbor-UCLA Medical Center. The primary outcome will be duration of hospitalization. Approximately 520 subjects will be enrolled (approximately 60 at this center) over 18 months.