HealthyNCT02899234
Acute Cardiorespiratory Effects of E-cigarette Inhalation
A study testing E-cigarette in people with Healthy, run by Umeå University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- E-cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Intermittent/sporadic cigarette smoking
- Normal clinical examination
- Normal EKG
- Normal blood tests
- Normal lung function
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Medicine, Lung and Allergy section, University Hospital
Umeå
About this study
Official title: Acute Health Effects of Exposure to Active E-cigarette Inhalation in Healthy Volunteers
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.
- Conditions
- Healthy
- Being tested
- E-cigarette
- Keywords
- Nicotine, Electronic Cigarette
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigaretteOther
A third generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine-free e-cigarette | Active comparator | Subjects will actively inhale nicotine-free vapor prior to blood samples and various non-invasive cardiopulmonary tests. Receives: Other: E-cigarette |
| Nicotine e-cigarette | Active comparator | Subjects will actively inhale nicotine containing vapor prior to blood samples and various non-invasive cardiopulmonary tests. Receives: Other: E-cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Stiffness
Pulse wave analysis (PWA), pulse wave velocity (PWV). Expressed as Pulse wave velocity (m/s) och augmentation index adjusted for pulse 75 (%).
Measured: 1 day
Secondary outcomes (4)
Lung function
Assessed using spirometry testing.
Measured: 1 day
Cardiovascular biomarkers
Blood samples are taken in order to assess cardiovascular biomarkers using microassay testing.
Measured: 1 day
Impulse oscillometry
Non-invasive measurement by which to evaluate large and small airway resistance, and thereby also airflow obstruction.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Jenny Bosson, Umeå University
- Investigators
- Jenny A Bosson, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899234
- Sponsor's protocol ID
- Umu-104-31
- Status last verified
- Oct 2018
- First submitted
- 8 Sep 2016
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Health Effects of Exposure to Active E-cigarette Inhalation in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02899234
- Acronym / sponsor ID
- Umu-104-31
- Conditions
- Healthy
- Keywords
- Nicotine, Electronic Cigarette
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Sep 2016
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine-free e-cigarette | Active comparator | Other: E-cigaretteSubjects will actively inhale nicotine-free vapor prior to blood samples and various non-invasive cardiopulmonary tests. |
| Nicotine e-cigarette | Active comparator | Other: E-cigaretteSubjects will actively inhale nicotine containing vapor prior to blood samples and various non-invasive cardiopulmonary tests. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Intermittent/sporadic cigarette smoking
- Normal clinical examination
- Normal EKG
- Normal blood tests
- Normal lung function
Key exclusion criteria (7 listed)
- Cardiovascular disease
- Respiratory disease
- Systemic or chronic disorders or disease
- Symptoms of infection or inflammation within 2 weeks of the study
- BMI≥30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-cigaretteA third generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings. | Other | Nicotine e-cigarette, Nicotine-free e-cigarette |
Primary outcome
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 (%).
4 secondary outcomes
Lung function
Time frame: 1 day
Cardiovascular biomarkers
Time frame: 1 day
Impulse oscillometry
Time frame: 1 day
Microcirculation assessment
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny A Bosson, MD, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-cigarette in people with Healthy, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Stiffness (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2018.