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Acute Cardiorespiratory Effects of E-cigarette Inhalation

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ClinicalTrials.gov Identifier: NCT02899234
Recruitment Status : Active, not recruiting
First Posted : September 14, 2016
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Jenny Bosson, Umeå University

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.

Condition or disease Intervention/treatment Phase
Healthy Other: E-cigarette Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Acute Health Effects of Exposure to Active E-cigarette Inhalation in Healthy Volunteers
Study Start Date : September 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

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

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Lung function [ Time Frame: 1 day ]
    Assessed using spirometry testing.

  2. Cardiovascular biomarkers [ Time Frame: 1 day ]
    Blood samples are taken in order to assess cardiovascular biomarkers using microassay testing.

  3. Impulse oscillometry [ Time Frame: 1 day ]
    Non-invasive measurement by which to evaluate large and small airway resistance, and thereby also airflow obstruction.

  4. Microcirculation assessment [ Time Frame: 1 day ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899234


Locations
Sweden
Dept of Medicine, Lung and Allergy section, University Hospital
Umeå, Sweden
Sponsors and Collaborators
Umeå University
Karolinska Institutet
Investigators
Principal Investigator: Jenny A Bosson, MD, PhD Umeå University

Responsible Party: Jenny Bosson, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT02899234     History of Changes
Other Study ID Numbers: Umu-104-31
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jenny Bosson, Umeå University:
Nicotine
Electronic Cigarette

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action