Healthy VolunteersNCT02143310
A Study to Evaluate the Safety of Electronic Vapor Products for 2 Years
A study testing EVP in people with Healthy Volunteers, run by Fontem Ventures BV at 2 sites in United Kingdom.
Trial summary
Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes devices/systems. These may look like conventional cigarettes but do not contain tobacco. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- EVP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2014to 29 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject who participated in the EVP G1 S2 study (S2)
- Willingness to use the EVP provided by the sponsor for two years as the only nicotine containing product
- No clinically significant abnormalities during the S2 study
Who cannot join
- Subjects who have used nicotine replacement therapy during the S2 study
- Subjects with relevant illness history
- Subjects with history of drug or alcohol abuse
- Subjects with lung function test or vital signs considered unsuitable Subjects who are trying to stop smoking
- Female subjects who are pregnant, or unwilling to use acceptable contraceptive method for the duration of the study.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Covance Clinical Research Unit
Leeds, England, LS2 9LH
Simbec Research
Merthyr Tydfil, Wales, CF48 4DR
About this study
Official title: A Multi-Centre Study to Evaluate the Safety of Use of Electronic Vapour Products for Two Years
Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes devices/systems. These may look like conventional cigarettes but do not contain tobacco.
The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.
This trial is to evaluate the safety and tolerability of an EVP over two years.
- Conditions
- Healthy Volunteers
- Being tested
- EVP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVPDevice
| Study group | Role | What they receive |
|---|---|---|
| EVP | Experimental | Subject who use the EVP for up to 2 years Receives: Device: EVP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Sitting systolic blood pressure (mmHg)
Measured: 24 months
Electrocardiogram (ECG): PR Interval
In electrocardiography, the PR interval is the period that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex. Variations in the PR interval can be associated with certain medical conditions.
Measured: 24 months
Lung Function Tests
Forced Vital Capacity (FVC)
Measured: 24 months
Clinical Laboratory Parameters
High density lipoprotein (HDL) cholesterol, change from baseline (BL)
Measured: 24 months
Secondary outcomes (3)
Nicotine Withdrawal Symptoms
Nicotine withdrawal symptoms were measured using the revised Minnesota Nicotine Withdrawal Scale (MWS-R) questionnaire. Extended total scores were used, i.e. the sum of the scores of all 15 questions of the questionnaire. Symptoms (e.g. angry, irritable, frustrated, depressed, restless, insomnia) were rated from 0 (none) to 4 (severe). Extended total scores may range from 0 to a maximum of 60.
Measured: 24 Months
Biomarkers of Exposure to Nicotine
The exposure to nicotine was measured by quantifying the change from BL in the amount of nicotine equivalents excreted in urine in 24-hours (AE24h).
Measured: 24 months
Biomarkers of Effect
Change from BL in the level of white blood cells.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startMay 2014
- Primary completion29 Dec 2016
- Study completion29 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fontem Ventures BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Bush, MD, Principal investigator, Covance Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143310
- Sponsor's protocol ID
- EVP G1 S3
- Status last verified
- Apr 2019
- First submitted
- 9 May 2014
- Last updated
- 1 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre Study to Evaluate the Safety of Use of Electronic Vapour Products for Two Years
- ClinicalTrials.gov ID
- NCT02143310
- Acronym / sponsor ID
- EVP G1 S3
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Fontem Ventures BVIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- 29 Dec 2016 (actual)
- Study completion
- 29 Dec 2016 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Posted 1 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes devices/systems. These may look like conventional cigarettes but do not contain tobacco.
The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.
This trial is to evaluate the safety and tolerability of an EVP over two years.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVP | Experimental | Device: EVPSubject who use the EVP for up to 2 years |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject who participated in the EVP G1 S2 study (S2)
- Willingness to use the EVP provided by the sponsor for two years as the only nicotine containing product
- No clinically significant abnormalities during the S2 study
Key exclusion criteria (5 listed)
- Subjects who have used nicotine replacement therapy during the S2 study
- Subjects with relevant illness history
- Subjects with history of drug or alcohol abuse
- Subjects with lung function test or vital signs considered unsuitable Subjects who are trying to stop smoking
- Female subjects who are pregnant, or unwilling to use acceptable contraceptive method for the duration 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 |
|---|---|---|
| EVP | Device | EVP |
Primary outcome
Blood Pressure
Time frame: 24 months
Sitting systolic blood pressure (mmHg)
Electrocardiogram (ECG): PR Interval
Time frame: 24 months
In electrocardiography, the PR interval is the period that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex. Variations in the PR interval can be associated with certain medical conditions.
Lung Function Tests
Time frame: 24 months
Forced Vital Capacity (FVC)
Clinical Laboratory Parameters
Time frame: 24 months
High density lipoprotein (HDL) cholesterol, change from baseline (BL)
3 secondary outcomes
Nicotine Withdrawal Symptoms
Time frame: 24 Months
Biomarkers of Exposure to Nicotine
Time frame: 24 months
Biomarkers of Effect
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Screening Protocol
Pain
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.
Jim Bush, MD principal investigator
Covance Clinical Research Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVP in people with Healthy Volunteers, run by Fontem Ventures BV at 2 sites in United Kingdom.
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 3 inclusion and 5 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 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blood Pressure (time frame: 24 months). The study lists 4 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 1 Jul 2019.