NCT03153228Unknown不适用
The Comparison of Biomarkers of Acute Response to Cigarette Smoking and E-cigarettes Smoking Assesed in Exhaled Breath Condensate in Healthy Smokers of Traditional and Electronical Cigarettes.
Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2017年5月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Inflammatory markers in exhaled breath condensate
研究概览
简要总结
Electronical cigarettes, also known as "e-cigarettes" are a new phenomenon, which steadily wins more aprobation among smokers. However, there exists no much data concerning the effects of acute exposure to electronic cigarettes vapour on the respiratory system.
The aim of the present study is to evaluate and compare the acute response to electronic and traditional cigarettes in healthy smokers.
详细描述
The aim of the study is:
- to evaluate the acute response to traditional cigarettes on the respiratory system
- to evaluate the acute response to electronic cigarettes on the respiratory system
- to assess the relationship between the type of smoked cigarettes (traditional vs. electronic) and concentration of markers of airway inflammation released in healthy smokers
Material and methods:
- 29 healthy smokers of traditional cigarettes
- 29 healthy smokers of electronic cigarettes
- 29 healthy, nonsmoking volunteers
After 8 hours of smoking abstinence:
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy smokers of traditional cigarettes - min. 1 packyear
- •healthy smokers of e-cigarettes - min. 1 year of smoking history
- •control group - healthy nonsmoking volunteers without any history of lung disease
排除标准
- •age below 18 years
- •inhaled corticosteroid therapy at least 6 weeks prior to study enrollment
- •any co-morbidities
- •respiratory infections at least 6 weeks prior to study enrollment
结局指标
主要结局
Inflammatory markers in exhaled breath condensate
时间窗: Approximately 1-2 months after completion of study procedures in all patients
Inflammatory markers in exhaled breath condensate in healthy subjects, smokers of traditional cigarettes and e-cigarette smokers
次要结局
未报告次要终点
研究者
研究点 (1)
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