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CompletedNCT02899234Updated Oct 4, 2018

Acute Cardiorespiratory Effects of E-cigarette Inhalation

An interventional study of E-cigarette in Healthy, sponsored by Umeå University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-04.

Sponsored by Umeå University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Nicotine
  • Electronic Cigarette
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 19 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
19 participants (actual)

Study arms

  • Active comparator
    Nicotine-free e-cigarette

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

    Other: E-cigarette

  • Active comparator
    Nicotine e-cigarette

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

    Other: E-cigarette

Interventions

  • OtherE-cigarette

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

06

What researchers measure

Primary outcomes

  1. Arterial Stiffness

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

    Time frame: 1 day

Secondary outcomes

  1. Lung function

    Assessed using spirometry testing.

    Time frame: 1 day

  2. Cardiovascular biomarkers

    Blood samples are taken in order to assess cardiovascular biomarkers using microassay testing.

    Time frame: 1 day

  3. Impulse oscillometry

    Non-invasive measurement by which to evaluate large and small airway resistance, and thereby also airflow obstruction.

    Time frame: 1 day

  4. 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.

    Time frame: 1 day

07

Study locations

1 site
  • Dept of Medicine, Lung and Allergy section, University Hospital
    Umeå, Sweden
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02899234
Lead sponsor
Umeå University
Collaborators
Karolinska Institutet
Responsible party
Jenny Bosson (MD, PhD, Umeå University) — Principal investigator
First posted
Sep 14, 2016
Start date
Sep 2016
Primary completion
May 2018
Completion
Jun 2018
Last update
Oct 4, 2018

Study contacts

Jenny A Bosson, MD, PhD
principal investigator · Umeå University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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