Healthy VolunteersNCT02029196
A Study to Evaluate the Safety Profile of an e-Vapour Product
A study testing E-vapour product and Conventional cigarette in people with Healthy Volunteers, run by Imperial Brands PLC 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 or electronic nicotine delivery 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?
- E-vapour product and Conventional cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Dec 2013to Nov 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
- Body Mass Index (BMI) of 18-35kg/m2
- Subjects must be established smokers
- Subjects must have smoked five to 30 cigarettes per day for at least one year
Who cannot join
- Subjects who have used nicotine replacement therapy within 14 days of the screening
- Subjects who have donated blood within 12 months preceding study
- Subjects with relevant illness history
- Subjects positive for hepatitis or Human Immunodeficiency Virus (HIV)
- 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 9HL
Simbec Research
Merthyr Tydfil, Wales, CF48 4DR
About this study
Official title: A Randomised, Parallel Group, Multi-centre Study to Evaluate the Safety Profile of the ITG EVP G1 Product
Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes or electronic nicotine delivery 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 of an e-vapour product.
- Conditions
- Healthy Volunteers
- Being tested
- E-vapour product, Conventional cigarette
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-vapour productOther
Smokers of conventional cigarettes who switch to use an e-vapour product.
Conventional cigaretteOther
Smokers of conventional cigarettes who continue smoking conventional cigarettes.
| Study group | Role | What they receive |
|---|---|---|
| e-vapour product (EVP) | Experimental | Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP). Receives: Other: E-vapour product |
| Conventional cigarette (CC) | Active comparator | Subjects who continue smoking their usual conventional cigarette (CC) brand. Receives: Other: Conventional cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Frequency of adverse events
Measured: 12 weeks
Secondary outcomes (1)
Exhaled Carbon Monoxide
Level of exhaled carbon monoxide at Week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2016
- Study completionNov 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial Brands PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Bush, MD, Principal investigator, Covance Clinical Research Unit, Springfield House, Hyde Street, Leeds LS2 9LH, UKGirish Sharma, MD, Principal investigator, Simbec Research, Merthyr Tydfil, CF48 4DR, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029196
- Sponsor's protocol ID
- ITG EVP G1 S2
- Status last verified
- Jan 2017
- First submitted
- 19 Dec 2013
- Last updated
- 21 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Parallel Group, Multi-centre Study to Evaluate the Safety Profile of the ITG EVP G1 Product
- ClinicalTrials.gov ID
- NCT02029196
- Acronym / sponsor ID
- ITG EVP G1 S2
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Imperial Brands PLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2013 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Posted 21 Mar 2017
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 or electronic nicotine delivery 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 of an e-vapour product.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e-vapour product (EVP) | Experimental | Other: E-vapour productSubjects who switch from using conventional cigarettes to using an e-vapour product (EVP). |
| Conventional cigarette (CC) | Active comparator | Other: Conventional cigaretteSubjects who continue smoking their usual conventional cigarette (CC) brand. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) of 18-35kg/m2
- Subjects must be established smokers
- Subjects must have smoked five to 30 cigarettes per day for at least one year
Key exclusion criteria (8 listed)
- Subjects who have used nicotine replacement therapy within 14 days of the screening
- Subjects who have donated blood within 12 months preceding study
- Subjects with relevant illness history
- Subjects positive for hepatitis or Human Immunodeficiency Virus (HIV)
- Subjects with history of drug or alcohol abuse
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-vapour productSmokers of conventional cigarettes who switch to use an e-vapour product. | Other | e-vapour product (EVP) |
| Conventional cigaretteSmokers of conventional cigarettes who continue smoking conventional cigarettes. | Other | Conventional cigarette (CC) |
Primary outcome
Adverse Events
Time frame: 12 weeks
Frequency of adverse events
1 secondary outcome
Exhaled Carbon Monoxide
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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, Springfield House, Hyde Street, Leeds LS2 9LH, UK
Girish Sharma, MD principal investigator
Simbec Research, Merthyr Tydfil, CF48 4DR, UK
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-vapour product and Conventional cigarette in people with Healthy Volunteers, run by Imperial Brands PLC 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 8 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 21 Mar 2017. 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 21 Mar 2017). 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?
Adverse Events (time frame: 12 weeks). 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 21 Mar 2017.