A Multi-center Study to Determine the Levels of Biomarkers of Potential Harm and Biomarkers of Exposure to Cigarette Smoke in Asian Adult Smokers and Non-smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,069
- 试验地点
- 1
- 主要终点
- The level of biomarkers of Exposure (BoExp) to HPHCs - present in cigarette smoke - in Asian smokers compared to non smokers
研究概览
简要总结
The purpose of this study is to determine biomarkers of exposure to Harmful and Potentially Harmful Constituents (HPHCs) in Cigarette Smoke and cardiovascular-related biomarkers in smokers and non smokers.
详细描述
Since Japanese mortality associated with cardiovascular disease (CVD) is lower than that in the USA although Japan is one of the top four tobacco consuming countries, this study aims to determine biomarkers of both level of exposure and CVD-related biological effects in Japanese smokers compared to non-smokers.
Biomarkers of Exposure (BoExp) include 2-naphthylamine (2-NA), 4-aminobiphenyl (4-ABP), 4-(methylnitrosaminoi)-1-(3-pyridil)-1-butanone (NNK), carbon monoxide (CO), nicotine, pyrene and 0-toluidine (o-TOL). CVD-related biomarkers include white blood cell (WBC) count, high sensitivity C-reactive protein (hs-CRP) and homocysteine in plasma; complemented with urinary 8-epi-prostaglandin F2α (8-epi-PGF2α), plasma malondialdehyde (MDA), urinary 11-DTXB2, plasma fibrinogen, high-density lipoprotein-cholesterol, triglycerides, sICAM-1, sVCAM-1 and von Willebrand Factor.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Smokers have smoked commercially available conventional cigarettes (CC)
- •With a minimum consumption of 10 CC per day for the last 5 years
排除标准
- •Any prior medical condition or chronic disease
- •Recent infection
- •History of cancer
- •Use of concomitant medication
- •History of alcohol abuse
- •Pregnant women
结局指标
主要结局
The level of biomarkers of Exposure (BoExp) to HPHCs - present in cigarette smoke - in Asian smokers compared to non smokers
时间窗: At Visit 2 (up to14 days after Visit 1)
To measure the level of smoking, at baseline the Fagerstrom nicotine dependence test and urinary cotinine are measured. For measurement of biomarkers of exposure, blood and 24 hour urine sampling are performed at V2.
The level of CVD-related biomarkers in Asian smokers compared to non smokers
时间窗: At Visit 2 (up to14 days after Visit 1)
次要结局
未报告次要终点