EFFICIENCY OF INHALED CORTICOSTEROIDS IN COPD

慢性阻塞性肺疾病(COPD)影响着1000万美国人 而且患病率正在增加，并成为死亡和残疾的原因。 虽然这种疾病可以在无症状阶段被识别出来，但几乎没有 已知干预措施以阻止肺功能加速下降 功能，这最终导致残疾。食道发炎 外周呼吸道是这种疾病的组织学特征，它是 认为这种炎症导致的临床表现为 疾病--肺泡壁破坏(肺气肿)和支气管 高反应性(支气管痉挛)。目前尚不清楚吸入的抗病毒药物 炎症剂，特别是吸入的皮质类固醇，可以改变 减少这种疾病的自然病史或降低发病率和死亡率。 本研究旨在确定，在多中心安慰剂中- 对照临床试验，是否使用吸入性皮质类固醇 (曲安奈德400杯，每日两次)可改变加速的 肺功能下降。北美的十个临床中心 将招募1,540名患有轻中度COPD的参与者 之前有5年的肺功能和支气管监测 肺健康研究中的反应性。一半的参与者将是 分配了活性药物，还有一半看起来一模一样的安慰剂。全 表示有兴趣的吸烟者将获得戒烟 心理咨询。肺活量测量将每六个月测量一次，最多4次 一年半的时间来确定症状、发病率、死亡率和 将测量生活质量以确定是否进行干预 改善健康状况。这项研究的次要目标是 确定这种干预是否有不利影响；衡量 药物依从性的模式；并确定是否有 某些受益于或易受不利影响的人群 效果。

Chronic obstructive pulmonary disease (COPD) affects 10 million Americans and is increasing in prevalence and as a cause of death and disability. Although the disease can be identified in the asymptomatic phase, little is known about interventions to arrest the accelerated decline in lung function, which eventually leads to disability. Inflammation of the peripheral airways is a histologic hallmark of this disorder, and it is thought that this inflammation leads to clinical manifestations of the disease--alveolar wall destruction (emphysema) and bronchial hyperreactivity (bronchospasm). It is not known whether inhaled anti- inflammatory agents, in particular, inhaled corticosteroids, can alter the natural history of this disease or reduce morbidity and mortality. The present study is designed to determine, in a multi-center placebo- controlled clinical trial, whether the use of an inhaled corticosteroid (triamcinolone acetonide 400 mug twice daily) can alter the accelerated decline in lung function. Ten clinical centers throughout North America will enroll 1,540 participants with mild to moderate COPD who have previously had 5-years of monitoring of lung function and bronchial reactivity in the Lung Health Study. Half of the participants will be assigned active drug, and half an identical-appearing placebo. All smoking participants who express interest will receive smoking cessation counseling. Spirometry will be measured every six months for up to 4 1/2 years to determine whether the symptoms, morbidity, mortality and quality of life will be measured to determine whether the intervention improves health status. Secondary objectives of the study will be to determine whether this intervention has adverse effects; to measure the patterns of adherence with the drug; and to determine whether there are certain subgroups of people who benefit or who are susceptible to adverse effects.