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临床试验/NCT02635620
NCT02635620已完成不适用

Changes in Lung Function Parameters, Bronchial Reactivity, State of Health and Smoking Behaviour Associated With Changing From Conventional Smoking to Electronic Cigarettes

Ludwig-Maximilians - University of Munich1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年10月最近更新:
适应症

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oliver Pogarell

Prof. Dr.

Ludwig-Maximilians - University of Munich

研究点 (1)

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