Acute Cardiorespiratory Effects of E-cigarette Inhalation

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02899234
• Other study ID #: Umu-104-31
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 2018

Study information

• Verified date: October 2018
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• E-cigarette
A third generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings.

Locations

Country	Name	City	State
Sweden	Dept of Medicine, Lung and Allergy section, University Hospital	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial Stiffness	Pulse wave analysis (PWA), pulse wave velocity (PWV). Expressed as Pulse wave velocity (m/s) och augmentation index adjusted for pulse 75 (%).	1 day
Secondary	Lung function	Assessed using spirometry testing.	1 day
Secondary	Cardiovascular biomarkers	Blood samples are taken in order to assess cardiovascular biomarkers using microassay testing.	1 day
Secondary	Impulse oscillometry	Non-invasive measurement by which to evaluate large and small airway resistance, and thereby also airflow obstruction.	1 day
Secondary	Microcirculation assessment	Microcirculation assessment is performed using the GlycoCheck system. This measures the endothelial cell surface layer non-invasively by applying a clinical videomicroscope to the sublingual arteries.	1 day