ANTI-LEUKOTRIENE THERAPY FOR COPD EXACERBATIONS

这个子项目是许多利用 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。 美国国立卫生研究院建立了COPD临床研究网络，以寻求新的COPD治疗方法。 COPD（慢性阻塞性肺疾病，也称为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，是美国第四大死亡原因。 该网络由美国十所大学的中心组成。 慢性阻塞性肺疾病（涉及肺部的严重疾病）的加重在发病率、死亡率和医疗保健费用方面造成了相当大的负担。2000年，COPD急性加重导致美国726，000例住院治疗和119，000例死亡。根据美国卫生保健研究和质量局的数据，2002年因COPD住院的患者平均住院时间为5.1天，费用为15，400美元。目前COPD急性加重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急性加重中发挥重要作用，因此我们建议研究抗白三烯治疗是否为需要住院治疗的COPD急性加重的管理提供额外的益处。抗白三烯治疗COPD急性加重的基本原理是基于COPD炎症介质的研究、抗白三烯治疗COPD的临床试验和抗白三烯治疗哮喘急性加重的临床试验。确定COPD急性加重的新治疗方法的动机是缩短住院时间应导致这种常见疾病管理的显着成本节约。 我们提出了一个平行组，双盲，安慰剂对照的随机试验的影响，14天的齐留通（600毫克口服，每天4次）除了常规护理与安慰剂（一种非活性药丸）除了常规护理在管理COPD急性加重需要住院治疗。患者将在Harbor-UCLA医学中心入院后12小时内入组研究。 主要结局为住院时间。在18个月内将入组约520例受试者（该中心约60例）。

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.