Changes in Lung Function Parameters, Bronchial Reactivity, State of Health and Smoking Behaviour Associated With Changing From Conventional Smoking to Electronic Cigarettes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- lung function
研究概览
简要总结
The purpose of this study is to investigate whether changing from conventional smoking to electronic cigarettes causes changes in conventional lung function parameters, bronchial reactivity, fractional exhaled nitric oxide (FeNO), Carbon monoxide (CO), health effects and smoking behaviour.
详细描述
STUDY BACKGROUND / RATIONALE / PURPOSE:
There is still little known about the health effects by vaping electronic cigarettes. Some former studies investigated the short term effects of vaping regarding lung function, respiratory resistance and FeNO (fractional exhaled nitric oxide). Flouris et al., 2013 did not found significant short term effects on conventional lung function parameters. Vardavas et al., 2012 also found no short term effects on conventional lung function parameters, but an increase of respiratory resistance and a decrease of FeNO. In contrast, Schober et al., 2014 observed an increase of FeNO after vaping electronic cigarettes.
Experimental studies have shown, that electronic cigarettes induce an inflammatory process in epithelial cells (Lerner et al., 2015; Wu, Jiang, Minor, and Chu, 2014). Lim and Kim, 2014 investigated the effects of e-liquids on the airway reactivity and inflammation on allergic sensitized mice. Reactivity and inflammation got worse.
Long term data is still missing. For this purpose we want to investigate lung function, airway reactivity, health status and smoking/vaping behaviour in smokers at the time they intend to start vaping and after 3 months.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •smoking ≥ 5 years
- •smoking ≥ 10 cigarettes per day
- •no intention to stop smoking within the last 3 months
- •using e-cigarettes with nicotine
- •no infection of airways at the time of measurements
- •e-cigarette group: intending to use e-cigarettes
- •control group: smoking cessation in the framework of a clinical conducted program
排除标准
- •pregnancy or breastfeeding
- •not speaking German
- •known allergy
- •acute psychiatric diseases, suicidal tendency
- •drug/substance/alcohol abuse
- •severe internal diseases
结局指标
主要结局
lung function
时间窗: 3 months
Tiffeneau-Index
respiratory tract inflammation activity
时间窗: 3 months
FeNO (exhaled nitric oxide)
quality of life
时间窗: 3 months
WHO quality of life - questionary
次要结局
未报告次要终点
研究者
Oliver Pogarell
Prof. Dr.
Ludwig-Maximilians - University of Munich
