NCT02029196已完成不适用
A Randomised, Parallel Group, Multi-centre Study to Evaluate the Safety Profile of the ITG EVP G1 Product
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
- 408
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes or electronic nicotine delivery devices/systems. These may look like conventional cigarettes but do not contain tobacco.
The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.
This trial is to evaluate the safety of an e-vapour product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) of 18-35kg/m2
- •Subjects must be established smokers
- •Subjects must have smoked five to 30 cigarettes per day for at least one year
排除标准
- •Subjects who have used nicotine replacement therapy within 14 days of the screening
- •Subjects who have donated blood within 12 months preceding study
- •Subjects with relevant illness history
- •Subjects positive for hepatitis or Human Immunodeficiency Virus (HIV)
- •Subjects with history of drug or alcohol abuse
- •Subjects with lung function test or vital signs considered unsuitable
- •Subjects who are trying to stop smoking
- •Female subjects who are pregnant, or unwilling to use acceptable contraceptive method for the duration of the study.
研究组 & 干预措施
e-vapour product (EVP)
Experimental
Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
干预措施: E-vapour product (Other)
Conventional cigarette (CC)
Active Comparator
Subjects who continue smoking their usual conventional cigarette (CC) brand.
干预措施: Conventional cigarette (Other)
结局指标
主要结局
Adverse Events
时间窗: 12 weeks
Frequency of adverse events
次要结局
- Exhaled Carbon Monoxide(12 weeks)
研究者
研究点 (2)
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