Exposure to Second-hand Aerosols Emitted by Use of Electronic Cigarettes in Real-life Conditions
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Airborne nicotine concentration (mg/m3)
研究概览
简要总结
Objective: To investigate in real-life conditions passive exposure to aerosols from the use of e-cigarettes among people who cohabit with e-cigarette users. A secondary objective is to investigate passive exposure to emissions from the use of conventional cigarettes and heated tobacco products among people who cohabit with users of these tobacco products.
Study design: This is an observational study conducted in four types of households: a) Homes with one exclusive e-cigarette user and at least one non-user (non-smoker), and no other users of any type of tobacco products. In these homes, one non-user and one user will be included in the study as participants ("type A" homes); b) Homes with one exclusive heated tobacco product (HTP) user and at least one non-user (non-smoker), and no other users of any type of tobacco products or e-cigarettes. In these homes, one non-user and one user will be included in the study as participants ("type B" homes); c) Homes with one exclusive manufactured cigarette smoker (not roll-your-own) and at least one non-smoker, and no other users of any type of tobacco products or e-cigarettes. In these homes, one non-smoker and one smoker will be included in the study as participants ("type C" homes); and d) Homes where no one uses e-cigarettes or consumes any other type of tobacco products (smoke-free homes). In these homes, one adult volunteer will be included in the study as a participant ("type D" homes).
The study will be conducted in 4 countries: Greece (Athens), Italy (Milan), Spain (Barcelona) and the UK (Edinburgh). Overall, the sample in each participating country will consist of the types of participants mentioned above, with a total of 250 participants.
Measurements: Passive exposure to e-cigarette aerosols will be assessed by measuring particulate matter (PM2.5) and airborne nicotine in the main room of homes during 7 days. Participants' saliva samples will be collected for nicotine and cotinine assessment. In addition, participants will be asked to fill in a personal diary about the use of e-cigarettes, second-hand exposure to e-cigarette aerosols (SHA) and exposure to second-hand smoke (SHS) produced by the use of conventional cigarettes.
详细描述
Aims: The main objective of this study is to investigate in real-life conditions passive exposure to aerosols from the use of e-cigarettes among people who cohabit with e-cigarette users. A secondary objective is to investigate passive exposure to emissions from the use of conventional cigarettes and heated tobacco products among people who cohabit with users of these tobacco products.
Study design
This is an observational study conducted in four types of households:
- Homes with one exclusive e-cigarette user and at least one non-user (non-smoker), and no other users of any type of tobacco products. In these homes, one non-user and one user will be included in the study as participants ("type A" homes).
- Homes with one exclusive heated tobacco product (HTP) user and at least one non-user (non-smoker), and no other users of any type of tobacco products or e-cigarettes. In these homes, one non-user and one user will be included in the study as participants ("type B" homes).
- Homes with one exclusive manufactured cigarette smoker (not roll-your-own) and at least one non-smoker, and no other users of any type of tobacco products or e-cigarettes. In these homes, one non-smoker and one smoker will be included in the study as participants ("type C" homes).
- Homes where no one uses e-cigarettes or consumes any other type of tobacco products (smoke-free homes). In these homes, one adult volunteer will be included in the study as a participant ("type D" homes).
The study will be conducted in 4 countries: Greece (Athens), Italy (Milan), Spain (Barcelona) and the UK (Edinburgh).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-e-cigarette and non-tobacco-product users
- •Adult (18 years old and above)
- •Non e-cigarette user (never or former e-cigarette user >1 month)
- •Non-user of any kind of tobacco product (never or former user >1 month)
- •[Only for type D homes]: other household members should not be users of tobacco products or e-cigarettes
- •E-cigarette users
- •Adult (18 years old and above)
- •E-cigarette exclusive user for at least 1 month
- •Daily use of e-cigarettes inside home
- •Cohabiting with at least one non-tobacco product nor e-cigarette user
- •Other household members should not be users of any tobacco products or e-cigarettes
- •Heated tobacco product users
- •Adult (18 years old and above)
- •HTP exclusive user for at least 1 month
- •Daily use of HTP inside home
- •Cohabiting with at least one non-tobacco product nor e-cigarette user
- •Other household members should not be users of tobacco products or e-cigarettes
- •Manufactured cigarette smoker
- •Adult (18 years old and above)
- •Manufactured cigarette exclusive smoker (not roll-your-own) for at least 6 months
- •Daily smoking inside home
- •Cohabiting with at least one non-tobacco product nor e-cigarette user
- •Other household members should not be users of tobacco products or e-cigarettes
排除标准
- •For all participants:
- •To be daily exposed to SHS from tobacco products or to SHA from e-cigarettes in places other than home.
结局指标
主要结局
Airborne nicotine concentration (mg/m3)
时间窗: 7 days
Median airborne nicotine concentration (1h measurements with active sampling and 7-day continuous of passive sampling) in the home environment
次要结局
- Particulate matter concentration (PM2.5; in mg/m3)(7 days)
- Nicotine, cotinine, TSNAs and propylene glycole concentrations in saliva samples (in ng/ml)(1st day and the 7th day (pre-; post))
- Metals, nicotine, cotinine and TSNAs concentrations in urine samples (in ng/ml)(One measurement; day 7 of the observational study)