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: 2226421
• 负责人: PAUL David SCANLON
• 金额: $ 44.51万
• 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 1999-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2226421
• 关键词: chronic obstructive pulmonary disease; clinical trials; cooperative study; corticosteroids; drug adverse effect; human subject; human therapy evaluation; respiratory disorder chemotherapy; respiratory function; respiratory therapy; 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.

慢性阻塞性肺疾病（COPD）影响1000万美国人 并且正在增加患病率，并且是死亡和残疾的原因。 尽管该疾病可以在无症状阶段鉴定 知道干预措施以阻止肺的加速下降 功能，最终导致残疾。 发炎 外围气道是这种疾病的组织学标志，它是 尽管这种炎症导致了 疾病 - 肺泡壁破坏（肺气肿）和支气管 过度反应性（支气管痉挛）。 尚不清楚吸入 炎症剂，尤其是吸入的皮质类固醇，会改变 这种疾病的自然病史或降低发病率和死亡率。 本研究旨在在多中心安慰剂中确定 对照临床试验，是否使用吸入皮质类固醇 （Triamcinolone acotonide 400杯每天两次）可以改变加速的 肺功能下降。 整个北美的十个临床中心 将注册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 肺部健康研究中的反应性。 一半的参与者将 分配活性药物，一半相同的安慰剂。 全部 表达兴趣的吸烟参与者将接受戒烟 咨询。 肺活量测定法每六个月测量最多4 1/2 确定治疗是否会改变肺部下降的几年 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 干预是否改善健康状况。 次要目标 该研究将确定该干预措施是否不良 效果；测量使用药物依从性的模式；然后 确定是否有某些受益的人或 他们容易受到不利影响。