Acute Cardiorespiratory Effects of E-cigarette Inhalation
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
E-cigarette
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring Nicotine, Electronic Cigarette
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
Sites / Locations
- Dept of Medicine, Lung and Allergy section, University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nicotine-free e-cigarette
Nicotine e-cigarette
Arm Description
Subjects will actively inhale nicotine-free vapor prior to blood samples and various non-invasive cardiopulmonary tests.
Subjects will actively inhale nicotine containing vapor prior to blood samples and various non-invasive cardiopulmonary tests.
Outcomes
Primary Outcome Measures
Arterial Stiffness
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
Lung function
Assessed using spirometry testing.
Cardiovascular biomarkers
Blood samples are taken in order to assess cardiovascular biomarkers using microassay testing.
Impulse oscillometry
Non-invasive measurement by which to evaluate large and small airway resistance, and thereby also airflow obstruction.
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.
Full Information
NCT ID
NCT02899234
First Posted
September 8, 2016
Last Updated
October 3, 2018
Sponsor
Umeå University
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02899234
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
Collaborators
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Nicotine, Electronic Cigarette
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nicotine-free e-cigarette
Arm Type
Active Comparator
Arm Description
Subjects will actively inhale nicotine-free vapor prior to blood samples and various non-invasive cardiopulmonary tests.
Arm Title
Nicotine e-cigarette
Arm Type
Active Comparator
Arm Description
Subjects will actively inhale nicotine containing vapor prior to blood samples and various non-invasive cardiopulmonary tests.
Intervention Type
Other
Intervention Name(s)
E-cigarette
Intervention Description
A third generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings.
Primary Outcome Measure Information:
Title
Arterial Stiffness
Description
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 Outcome Measure Information:
Title
Lung function
Description
Assessed using spirometry testing.
Time Frame
1 day
Title
Cardiovascular biomarkers
Description
Blood samples are taken in order to assess cardiovascular biomarkers using microassay testing.
Time Frame
1 day
Title
Impulse oscillometry
Description
Non-invasive measurement by which to evaluate large and small airway resistance, and thereby also airflow obstruction.
Time Frame
1 day
Title
Microcirculation assessment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenny A Bosson, MD, PhD
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Medicine, Lung and Allergy section, University Hospital
City
Umeå
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Acute Cardiorespiratory Effects of E-cigarette Inhalation
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