Clinical Impact of Secondhand Exposure to Aerosols Produced by E-cigarettes on the Respiratory System (TackSHS Project)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mechanical functions of respiratory system
研究概览
简要总结
Limited studies have evaluated potential exposure to secondhand e-cigarette aerosol, an indication of impact on indoor air quality. Also limited are the studies regarding direct passive exposure of humans and most of these studies have limitations, such as the small number of participants, the different methodology and devices used, or the fact that they are laboratory studies, where exposure parameters differ significantly from the actual user's habit and device. Therefore, TackSHS Project has foreseen an intervention study of cross-over design in similar to real-life conditions that aims to assess the mediating effect of e-cigarette battery output on pulmonary outcomes and indexes to provide a better understanding of the extent to which passive exposure to aerosols produced by use of e-cigarette impacts exhaled NO and exhaled breath condensate metabolites.
详细描述
This study is a part of a larger research project (TackSHS) funded by the European Union's Horizon 2020 Research and Innovation Programme (Grant Agreement No 681040). The current study main aim is to assess the impact of passive exposure to aerosols produced by use of e-cigarettes on indexes of lung function (respiratory mechanics and exhaled biomarkers) among healthy adults.
To achieve this objective, a laboratory based intervention study of cross-over design will be conducted at the "George D Behrakis RESEARCH LAB" of the Hellenic Cancer Society. Specifically, three trial arms will be performed (no exposure to e-cigarette aerosols (1) vs. low e-cigarette aerosols exposure (2) vs. high e-cigarette aerosols exposure (3)) with each subject participating in each of the three trial arms. Each trial arm is based around two battery power outputs, one of the key factors related to the production of e-cigarette aerosols.
Sample size:
The study sample will be 40 participants. The participants will be randomized to a sequence of exposures, and thus all the participants are requested to participate in all three trial-arms. In total, 120 person-exposures will take place (3 trial-arms x 40 adults) during the duration of this study, leading to 240 pre and post measurements.
Study Population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For non-smokers:
- •Age 18-35
- •Non-smokers (exhaled CO measurement before each session), or
- •Ex-smokers (> 1 year)
- •Healthy as by non-significant medical history, normal physical examination and flow volume loop within predicted normal limits (ATS/ERS Task Force 2005)
- •Normal BMI< 30
- •For e-cigarette users
- •Age 18-35
- •Normal BMI< 30
- •Experienced e-cig users:>2 months use
- •Healthy as by non-significant medical history, normal physical examination and flow volume loop within predicted normal limits (ATS/ERS Task Force 2005)
排除标准
- •For non-smokers
- •Smokers of all kinds and devices, ex-smokers (< 1 year)
- •Age <18, >35
- •Pregnancy, lactation
- •Ongoing or recent illness (<4 weeks prior to study), recent infection (<4 weeks)
- •Acute or chronic condition or disease (diabetes, asthma, COPD, congenital heart disease, arrhythmia, hypertension...)
- •Medication of any kind (<2 weeks prior to study)
- •For e-cigarette users
- •Non-smokers
- •Age <18, >35
- •Pregnancy, lactation
- •Ongoing or recent illness (<4 weeks prior to study), recent infection (<4 weeks).
- •Acute or chronic condition or disease (diabetes, asthma, COPD, congenital heart disease, arrhythmia, hypertension...)
- •Medication of any kind (<2 weeks prior to study)
结局指标
主要结局
Mechanical functions of respiratory system
时间窗: The measurements (IOS, FeNO, EBC) will be performed in each trial arm immediately after the exposure; the 30 minutes time frame applies for the collective measurements and it is the time needed to perform all 3 tests according to the ATS/ERS guidelines.
By means of impulse oscillometry system (IOS) the following idicators will be measured: Respiratory system total Impedance (Z5), Resistance (R5, R10, R20), Reactance (X5, X10, X20), Resonant Frequency (Rf), Frequency dependence of resistance (fdr), Area AX.
Fraction of Exhaled Nitric Oxide (FeNO)
时间窗: The measurements (IOS, FeNO, EBC) will be performed in each trial arm immediately after the exposure; the 30 minutes time frame applies for the collective measurements and it is the time needed to perform all 3 tests according to the ATS/ERS guidelines.
Measurement of airway eosinofilic inflammation
次要结局
- Exhaled Breath Condensate (EBC)(The measurements (IOS, FeNO, EBC) will be performed in each trial arm immediately after the exposure; the 30 minutes time frame applies for the collective measurements and it is the time needed to perform all 3 tests according to the ATS/ERS guidelines.)