Acute Health Effects of Exposure to Active E-cigarette Inhalation in Healthy Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Umeå University
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Arterial Stiffness
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Intermittent/sporadic cigarette smoking
- •Normal clinical examination
- •Normal EKG
- •Normal blood tests
- •Normal lung function
Exclusion Criteria
- •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
Arms & Interventions
Nicotine-free e-cigarette
Subjects will actively inhale nicotine-free vapor prior to blood samples and various non-invasive cardiopulmonary tests.
Intervention: E-cigarette (Other)
Nicotine e-cigarette
Subjects will actively inhale nicotine containing vapor prior to blood samples and various non-invasive cardiopulmonary tests.
Intervention: E-cigarette (Other)
Outcomes
Primary Outcomes
Arterial Stiffness
Time Frame: 1 day
Pulse wave analysis (PWA), pulse wave velocity (PWV). Expressed as Pulse wave velocity (m/s) och augmentation index adjusted for pulse 75 (%).
Secondary Outcomes
- Impulse oscillometry(1 day)
- Microcirculation assessment(1 day)
- Lung function(1 day)
- Cardiovascular biomarkers(1 day)
Investigators
Jenny Bosson
MD, PhD
Umeå University