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临床试验/NCT05260827
NCT05260827已完成不适用

The Effects of Heated Tobacco Products Use on Lung Function and Volatile Organic Compounds in Exhaled Air

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Volatile organic compounds in exhaled air, nanogram/l (please see study description for specification of VOC)

研究概览

简要总结

This is a human randomized controlled cross-over study where we investigate the effects of heated tobacco products (HTP) on lung function and on assessing volatile organic compounds in exhaled air.

详细描述

The World Health Organization estimates that smoking is one of the leading causes of premature death worldwide with an estimated 5-8 million lives lost annually due to tobacco usage.

Heated tobacco products (HTP) is a new form of tobacco products. HTP usually consists of a pod with tobacco that is mixed with glycerol which is inserted into a heating chamber. HTP is not combusted but only heated. Previous studies into smoking cessation with regular cigarettes and electronic cigarettes have suggested a risk for double usage instead of cessation, augmenting a nicotine addiction. There is a risk that HTP use simply enhances nicotine usage and smoking addiction.

There is limited data on the health effects of HTP. A majority of the studies available have reported conflicts of interest to manufacturers of HTP. It has been shown that aerosols from HTP contain toxic compounds and free radicals just as in regular cigarette smoke, albeit in lower concentrations (6-8). Furthermore, aerosols from HTP can spread in a room, enabling passive exposure (9). It has been shown that there is a decrease in harmful biomarkers in smokers that switch to HTP after 5 days of usage but also of a higher HTP consumption compared to regular smoking. There are few studies on effects of HTP in humans. We seek to assess the effects of HTP usage on lung function and the presence of volatile organic compounds in exhaled air using non invasive methods.

Subjects and criteria:

Twenty five male or female occasional tobacco users (age 18-40, maximum 10 cigarettes per month or 10 pouches of snus per month) will be included. They have to be healthy, having no preexisting conditions or take any medications. All subjects will have to complete a normal health declaration.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy, free from medication

排除标准

  • Any form of cardiovascular disease
  • Any form of pulmonary disease like asthma or COPD
  • Any form of systemic or chronic disorder like rheumatologic or metabolic diseases. - Symptoms of infection or inflammation within 4 weeks of the study
  • Pregnancy

研究组 & 干预措施

Heated tobacco product

Experimental

30 puffs of heated tobacco product IQOS

干预措施: Heated tobacco product (Other)

Sham

Experimental

sham heated tobacco product

干预措施: Heated tobacco product (Other)

结局指标

主要结局

Volatile organic compounds in exhaled air, nanogram/l (please see study description for specification of VOC)

时间窗: 120 minutes

in exhaled air

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

Magnus Lundbäck

PI

Karolinska Institutet

研究点 (2)

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