A Multi-Centre Study to Evaluate the Safety of Use of Electronic Vapour Products for Two Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 209
- 试验地点
- 4
- 主要终点
- Blood Pressure
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 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 and tolerability of an EVP over two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject who participated in the EVP G1 S2 study (S2)
- •Willingness to use the EVP provided by the sponsor for two years as the only nicotine containing product
- •No clinically significant abnormalities during the S2 study
排除标准
- •Subjects who have used nicotine replacement therapy during the S2 study
- •Subjects with relevant illness history
- •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
EVP
Subject who use the EVP for up to 2 years
干预措施: EVP (Device)
结局指标
主要结局
Blood Pressure
时间窗: 24 months
Sitting systolic blood pressure (mmHg)
Electrocardiogram (ECG): PR Interval
时间窗: 24 months
In electrocardiography, the PR interval is the period that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex. Variations in the PR interval can be associated with certain medical conditions.
Lung Function Tests
时间窗: 24 months
Forced Vital Capacity (FVC)
Clinical Laboratory Parameters
时间窗: 24 months
High density lipoprotein (HDL) cholesterol, change from baseline (BL)
次要结局
- Biomarkers of Exposure to Nicotine(24 months)
- Nicotine Withdrawal Symptoms(24 Months)
- Biomarkers of Effect(24 months)