Clinical trial NCT02899234: Acute Cardiorespiratory Effects of E-cigarette Inhalation
Official title: Acute Health Effects of Exposure to Active E-cigarette Inhalation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Nicotine
Electronic Cigarette
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2016-09-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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
* BMI≥30
* Pregnancy
* Current habitual cigarette smokers

Primary outcomes:
measure: Arterial Stiffness
timeFrame: 1 day
Secondary outcomes:
measure: Lung function
timeFrame: 1 day
measure: Cardiovascular biomarkers
timeFrame: 1 day
measure: Impulse oscillometry
timeFrame: 1 day
measure: Microcirculation assessment
timeFrame: 1 day
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Dept of Medicine, Lung and Allergy section, University Hospital
Study officials:
affiliation: Umeå University
name: Jenny A Bosson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: