HealthyESMOKENCT02532894
Effects of E-smoke on Levels of Endothelial Progenitor Cells and Microparticles in Healthy Volunteers
A study testing Electronic cigarette in people with Healthy, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
We plan to investigate the acute effects of inhaling e-cigarette vapor on cell function measured by microvesicles and endothelial progenitor cells. Micro vesicles are released upon either activation or apoptosis from different cell types such as platelets, leucocytes and endothelial cell. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Electronic cigarette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2014to Mar 2016
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
- sporadic cigarette smoking (<9 cigarettes per month)
Who cannot join
- Any form of cardiovascular disease
- Any form of pulmonary disease like asthma or COPD
- Any form of systemic or chronic disorder like rheumatologic or metabolic diseases.
- Active allergy within 4 weeks of the study
- Symptoms of infection or inflammation within 4 weeks of the study
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Institutionen för kliniska vetenskaper, Danderyds sjukhus
Danderyd, Stockholm County, 18288
About this study
We plan to investigate the acute effects of inhaling e-cigarette vapor on cell function measured by microvesicles and endothelial progenitor cells. Micro vesicles are released upon either activation or apoptosis from different cell types such as platelets, leucocytes and endothelial cell. Endothelial progenitor cells are a type of stem cells that circulate in the blood with the ability to differentiate to endothelial cells. Endothelial progenitor cells are inversely correlated to cardiovascular risk factors.
As a secondary endpoint we plan to investigate exhaled nitric oxide - a common inflammation marker used in asthmatic patients - after inhalation of electronic cigarette vapor.
- Conditions
- Healthy
- Being tested
- Electronic cigarette
- Keywords
- endothelial dysfunction, microvesicles, endothelial progenitor cells, electronic cigarettes
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic cigaretteDevice
Inhaling e-cigarette vapor
| Study group | Role | What they receive |
|---|---|---|
| Esmoke | Experimental | Inhaling e-cigarette vapor Receives: Device: Electronic cigarette |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of endothelial progenitor cells
Measured: 24 hours
Change in number of micro vesicles
Measured: 24 hours
Secondary outcomes (1)
Change in exhaled nitric oxide
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2014
- Study completionMar 2016
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.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Lundbäck, Karolinska Institutet
- Investigators
- Magnus Lundbäck, MD, PhD, Principal investigator, Institutionen för kliniska vetenskaper, Danderyds sjukhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532894
- Sponsor's protocol ID
- 214/552-31/4
- Acronym
- ESMOKE
- Status last verified
- Oct 2021
- First submitted
- 24 Aug 2015
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of E-smoke on Levels of Endothelial Progenitor Cells and Microparticles in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02532894
- Acronym / sponsor ID
- ESMOKE / 214/552-31/4
- Conditions
- Healthy
- Keywords
- endothelial dysfunction, microvesicles, endothelial progenitor cells, electronic cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Aug 2015 (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.
We plan to investigate the acute effects of inhaling e-cigarette vapor on cell function measured by microvesicles and endothelial progenitor cells. Micro vesicles are released upon either activation or apoptosis from different cell types such as platelets, leucocytes and endothelial cell. Endothelial progenitor cells are a type of stem cells that circulate in the blood with the ability to differentiate to endothelial cells. Endothelial progenitor cells are inversely correlated to cardiovascular risk factors.
As a secondary endpoint we plan to investigate exhaled nitric oxide - a common inflammation marker used in asthmatic patients - after inhalation of electronic cigarette vapor.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esmoke | Experimental | Device: Electronic cigaretteInhaling e-cigarette vapor |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy subjects
- sporadic cigarette smoking (<9 cigarettes per month)
Key exclusion criteria (6 listed)
- Any form of cardiovascular disease
- Any form of pulmonary disease like asthma or COPD
- Any form of systemic or chronic disorder like rheumatologic or metabolic diseases.
- Active allergy within 4 weeks of the study
- Symptoms of infection or inflammation within 4 weeks of the study
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 |
|---|---|---|
| Electronic cigaretteInhaling e-cigarette vapor | Device | Esmoke |
Primary outcome
Change in number of endothelial progenitor cells
Time frame: 24 hours
Change in number of micro vesicles
Time frame: 24 hours
1 secondary outcome
Change in exhaled nitric oxide
Time frame: 24 hours
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 11 Oct 2021.
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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.
Magnus Lundbäck, MD, PhD principal investigator
Institutionen för kliniska vetenskaper, Danderyds sjukhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic cigarette in people with Healthy, run by Karolinska Institutet 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 2 inclusion and 6 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 11 Oct 2021. 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?
Change in number of endothelial progenitor cells (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 11 Oct 2021.