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临床试验/NCT02899234
NCT02899234已完成不适用

Acute Health Effects of Exposure to Active E-cigarette Inhalation in Healthy Volunteers

Umeå University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2016年9月最近更新:
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
19
试验地点
1
主要终点
Arterial Stiffness

研究概览

简要总结

According to the World Health Organization cigarette smoking is today one of the leading single causes of preventable death and morbidity. The electronic cigarette (e-cigarette) has been marketed as a safer alternative to conventional cigarettes, and its global sales continue to grow exponentially each year. Despite growing e-cigarette use, scientific data on health effects are insufficient in some respects and completely lacking in others. Therefore the current study is designed to investigate the effects of active e-cigarette inhalation on the cardiovascular and respiratory systems.

详细描述

It is estimated that 6 million people worldwide lose their lives due to tobacco use yearly. On average, cigarette smokers are estimated to die 10 years earlier than non-smokers. Ischemic heart disease, chronic obstructive pulmonary disease, stroke, respiratory illness, lung cancer and other cancers have all been linked to tobacco use. In recent years the electronic cigarette (e-cigarette) has been introduced to the market as an alternative to traditional cigarette smoking. E-cigarettes have been aggressively marketed as a cheaper, healthier, cleaner alternative to smoking in both advertising and media outlets, primarily targeting women and adolescents. With limited knowledge of e-cigarette vaping health effects in humans it has been challenging for governments and health officials to give advice and regulate the use of this novel product.

In the current study investigators aim to investigate acute cardiovascular and respiratory effects after active inhalation of e-cigarette in healthy human subjects.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Intermittent/sporadic cigarette smoking
  • Normal clinical examination
  • Normal EKG
  • Normal blood tests
  • Normal lung function

排除标准

  • Cardiovascular disease
  • Respiratory disease
  • Systemic or chronic disorders or disease
  • Symptoms of infection or inflammation within 2 weeks of the study
  • Pregnancy
  • Current habitual cigarette smokers

研究组 & 干预措施

Nicotine-free e-cigarette

Active Comparator

Subjects will actively inhale nicotine-free vapor prior to blood samples and various non-invasive cardiopulmonary tests.

干预措施: E-cigarette (Other)

Nicotine e-cigarette

Active Comparator

Subjects will actively inhale nicotine containing vapor prior to blood samples and various non-invasive cardiopulmonary tests.

干预措施: E-cigarette (Other)

结局指标

主要结局

Arterial Stiffness

时间窗: 1 day

Pulse wave analysis (PWA), pulse wave velocity (PWV). Expressed as Pulse wave velocity (m/s) och augmentation index adjusted for pulse 75 (%).

次要结局

  • Impulse oscillometry(1 day)
  • Microcirculation assessment(1 day)
  • Lung function(1 day)
  • Cardiovascular biomarkers(1 day)

研究者

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

Jenny Bosson

MD, PhD

Umeå University

研究点 (1)

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