LUNG HEALTH STUDY--LONG TERM FOLLOW UP

肺部健康研究——长期随访

• 批准号: 2648187
• 负责人: Robert A. Wise
• 金额: $ 15.27万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-02-01 至 2003-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2648187
• 关键词: body weight; cardiovascular disorder epidemiology; chronic obstructive pulmonary disease; clinical depression; clinical research; comorbidity; cooperative study; disease /disorder proneness /risk; gender difference; human morbidity; human mortality; human subject; human therapy evaluation; quality of life; respiratory airway volume; respiratory disorder epidemiology; respiratory function; smoking cessation; tobacco abuse

The Lung Health Study (LHS), conducted from 1986-1994, demonstrated that a smoking intervention program in middle-aged long-term cigarette smokers can result in a highly significant beneficial effect on the rate of FEV1 decline over five years. However, FEV1 is only a surrogate marker for clinical outcomes of respiratory morbidity and mortality. The present study proposes long-term post-trial follow-up of former LHS participants to assess the incidence of morbidity and mortality from respiratory and cardiovascular diseases and other causes, as documented by hospital, clinic, and death records. A pulmonary function test 11 to 12 years after entry into the LHS is also proposed to determine long- term effects of the LHS smoking intervention program on lung function. The main objectives of the study are as follows: 1) to determine, using an intent-to-treat analysis, whether the LHS smoking intervention significantly reduces the incidence of clinically important respiratory and cardiovascular disease over a 12- to 15-year period following study enrollment; 2) to determine whether the beneficial effect of the smoking intervention program on measures of lung function persists through 11 to 12 years of follow-up; 3) to estimate the magnitude of the effects of FEV1 and FVC on the risks of cardiovascular and respiratory morbidity and mortality, after controlling for smoking history; 4) to study the role of other factors [gender, airways reactivity, weight gain, and co- morbidities] in determining the rate of decline in pulmonary function and the risks of cardiovascular and respiratory morbidity and mortality. All ten of the original LHS clinical centers plan to participate. To minimize bias, all surviving participants of the LHS will be invited to participated, giving a potential sample size of 5600.

1986 - 1994年进行的肺部健康研究（LHS）表明 中年长期香烟的吸烟干预计划 吸烟者可能会对速率产生极大的有益影响 FEV1在五年内下降。但是，FEV1只是一个代理 标记呼吸道发病和死亡率的临床结果。 本研究提出了以前LHS的长期审判后随访 参与者评估发病率和死亡率的发病率 如有记录，呼吸和心血管疾病以及其他原因 由医院，诊所和死亡记录。 肺功能测试11 还提出了进入LHS后12年以确定长期 LHS吸烟干预计划对肺功能的术语影响。 研究的主要目标如下：1）确定，使用 意图对治疗分析，LHS是否吸烟干预 显着降低了临床上重要呼吸的发生率 在研究后的12到15年中，心血管疾病和心血管疾病 注册; 2）确定吸烟的有益效果是否有益 肺功能度量的干预计划持续到11 到12年的随访； 3）估计效果的大小 FEV1和FVC的心血管和呼吸道发病风险 和死亡率，在控制吸烟史之后； 4）研究 其他因素的作用[性别，气道反应性，体重增加和共同 病毒性]在确定肺功能下降速度时 以及心血管和呼吸道发病率和死亡率的风险。 原始LHS临床中心的所有十个计划都计划参加。到 最小化偏见，所有幸存的LHS参与者都将被邀请 参与，潜在样本量为5600。