LUNG HEALTH STUDY--LONG TERM FOLLOW-UP

肺部健康研究——长期随访

• 批准号: 6151362
• 负责人: Richard Kanner
• 金额: $ 11.58万
• 依托单位: UNIVERSITY OF UTAH
• 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/6151362
• 关键词: body weight; cardiovascular disorder epidemiology; chronic obstructive pulmonary disease; clinical depression; clinical research; comorbidity; cooperative study; disease /disorder proneness /risk; emphysema; gender difference; human morbidity; human mortality; human subject; human therapy evaluation; longitudinal human study; 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. Of minimize bias, all surviving participants of the LHS will be invited to participate, giving a potential sample size of 5600.

1986 年至 1994 年进行的肺部健康研究 (LHS) 表明， 中年长期吸烟的吸烟干预计划 吸烟者会对吸烟率产生非常显着的有益影响 五年内 FEV1 下降。然而，FEV1 只是一个替代值 呼吸系统发病率和死亡率临床结果的标志物。 本研究建议对前 LHS 进行长期试验后随访 参与者评估发病率和死亡率 据记录，呼吸系统疾病和心血管疾病以及其他原因 按医院、诊所和死亡记录。 肺功能检查11 还建议进入 LHS 后 12 年确定长期 LHS 吸烟干预计划对肺功能的长期影响。 研究的主要目标如下： 1）确定、利用 意向治疗分析，LHS 吸烟干预是否 显着降低临床重要呼吸道疾病的发生率 研究后 12 至 15 年内的心血管疾病 注册; 2）确定吸烟是否有有益作用 肺功能测量干预计划持续到 11 12年的随访； 3）估计影响的大小 FEV1 和 FVC 对心血管和呼吸系统疾病风险的影响 控制吸烟史后的死亡率； 4）研究 其他因素的作用[性别、气道、反应性、体重增加和共同 发病率]确定肺功能下降率 以及心血管和呼吸系统发病和死亡的风险。 原来的 LHS 十个临床中心全部计划参加。的 最大限度地减少偏见，LHS 的所有幸存参与者将被邀请 参与，潜在样本量为 5600。