CLINICAL TRIAL OF INHALED STEROIDS IN COPD

吸入类固醇治疗慢性阻塞性肺病的临床试验

• 批准号: 3553606
• 负责人: PAUL David SCANLON
• 金额: $ 5.97万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-09-04 至 1998-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3553606
• 关键词: clinical trials; cooperative study; corticosteroids; drug adverse effect; emphysema; human therapy evaluation; respiratory disorder chemotherapy; respiratory function; therapy compliance

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 though that this inflammation leads to the 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 treatment will alter the decline in lung function. In addition, bronchial reactivity, respiratory 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 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.

慢性阻塞性肺病 (COPD) 影响着 1000 万美国人 其患病率正在增加，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，但很少 众所周知，可以采取干预措施来阻止肺功能加速下降 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， 尽管这种炎症会导致临床表现 疾病--肺泡壁破坏（肺气肿）和支气管 高反应性（支气管痉挛）。 目前尚不清楚是否吸入抗 炎症剂，特别是吸入皮质类固醇，可以改变 这种疾病的自然史或减少发病率和死亡率。 本研究旨在确定，在多中心安慰剂中 对照临床试验，是否使用吸入皮质类固醇 （曲安奈德 400 杯，每日两次）可以改变加速 肺功能下降。 遍布北美的十个临床中心 将招募 1,540 名患有轻度至中度慢性阻塞性肺病的参与者，他们患有 之前有过5年的肺功能和支气管监测 肺部健康研究中的反应性。 一半的参与者将 指定的活性药物和一半外观相同的安慰剂。 全部 表示有兴趣的吸烟参与者将获得戒烟服务 咨询。 肺活量测定将每六个月测量一次，最多 4 1/2 确定治疗是否会改变肺功能的衰退 功能。 此外，支气管反应性、呼吸道症状、 将测量发病率、死亡率和生活质量以确定 干预措施是否改善健康状况。 次要目标 研究的结果将确定这种干预措施是否有不利影响 影响；测量药物的依从性模式；并到 确定是否有某些人群受益或 容易受到不良影响的人。