EFFICACY OF INHALED CORTICOSTEROIDS IN COPD

慢性阻塞性肺疾病（COPD）影响着1000万美国人 并且作为死亡和残疾的一个原因，其发病率正在增加。 虽然这种疾病可以在无症状阶段被发现， 是已知的干预措施，以阻止肺的加速下降， 功能，最终导致残疾。 炎症 外周气道是这种疾病的组织学标志， 认为这种炎症导致了 疾病-肺泡壁破坏（肺气肿）和支气管 高反应性（支气管痉挛）。 目前尚不清楚吸入抗- 炎症剂，特别是吸入性皮质类固醇，可以改变 这种疾病的自然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- 对照临床试验，是否使用吸入性皮质类固醇 （曲安奈德400微克，每日两次）可以改变加速的 肺功能下降。 遍布北美的10个临床中心 将招募1，540名患有轻度至中度COPD的参与者， 以前有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 分配的活性药物和一半相同的安慰剂。 所有 表示有兴趣戒烟的参与者将获得戒烟 辅导 每6个月测量一次肺功能测定，最多持续4 1/2年，以确定是否有症状，发病率，死亡率和 生活质量将被衡量，以确定是否干预 改善健康状况。 本研究的次要目的是 确定这种干预是否有不利影响;衡量 与药物的依从性模式;并确定是否有 受益或易受不利影响的某些人群 方面的影响.

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.