Smoking, TobaccoVAPOURNCT03358953
The Cardiovascular Impacts of Electronic Cigarettes in Comparison to the Use of Nicotine Replacement Patches
A study testing Electron Cigarette and Nicotine Replacement Patch in people with Smoking, Tobacco, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
In Scotland tobacco-related illnesses account for in excess of 56,000 hospital admissions and a quarter of deaths each year. The resultant financial impact on NHS Scotland is over £300 million per annum. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco
- What is being tested?
- Electron Cigarette and Nicotine Replacement Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Dec 2016to 13 Jul 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18-65 years and wish to stop smoking. Smoker of at least 1-15 tobacco cigarette (TC) per day for ≥ six months Committed to attending weekly support sessions with NHSGGC Smokefree Services Must be willing to stop smoking tobacco cigarettes with the use of either nicotine replacement patches or an electronic cigarette with nicotine containing e-liquid.
Who cannot join
- Breastfeeding or pregnancy Use of EC or NRP within the past three months Uncontrolled hypertension - Blood pressure ≥165/95 mmHg
- Established history of cardiovascular defined as:
- Unstable angina, heart failure New York Heart Association (NYHA) Functional Classification classes III - IV Recent stroke, myocardial infarction, coronary artery bypass graft or percutaneous coronary angiogram within the last 3 months.
- Established renal disease defined as eGFR <45 Established history of peripheral vascular disease Established history of Chronic Obstructive Pulmonary Disease. Illicit drug use Severe concurrent medical condition that would prevent participation in study procedures or malignant neoplasm or with life expectancy ≤ 3 months.
- Major depressive illness or other psychiatric conditions. Participants who decline participation in the study or who are unable to provide informed consent
- History of allergies to active substances, excipients or delivery device (patch) in NRP or EC
- NRP: See current Summary of Product Characteristics
- EC: Nicotine, Propylene Glycol (PG), Glycerol and water.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Glasgow Clinical Research Facility
Glasgow, Scotland, G51 4TF
About this study
Official title: The Cardiovascular Impacts of Electronic Cigarettes to the Use of Nicotine Replacement Patches
In Scotland tobacco-related illnesses account for in excess of 56,000 hospital admissions and a quarter of deaths each year. The resultant financial impact on NHS Scotland is over £300 million per annum. To minimise the clinical and financial burden of tobacco on national healthcare systems, Scotland's tobacco control strategy aims to create a "tobacco-free" generation by 2034, with the prevalence of smoking in the adult population reduced to ≤5 %. The multifaceted approach focuses upon tobacco prevention, protection and cessation.
In relation to smoking cessation, the use of EC has exponentially increased since 2011, and EC are presently the most popular nicotine replacement product used in England. The Public Health England (PHE) Report published in August 2015 advocates the use of EC when other smoking cessation aids have failed.
Read the detailed description
Tobacco smoking (TS) remains a major health challenge for people in Scotland. EC are presently the most popular nicotine replacement product used in England. Recently NHS Greater Glasgow and Clyde (NHSGGC) have, like other Health Boards and Trusts in the UK, lifted the ban on ECs on hospital grounds. This decision has been based on recent evidence that ECs appear to be less harmful when compared to TS but it is acknowledged that the short- and long-term sequelae of ECs remain unknown. Systematic research focusing on the effectiveness of ECs on cardiovascular and pulmonary phenotypes is urgently needed.
The VAPOUR pilot study is a randomised control trial (RCT) investigating the short-term cardiorespiratory effects of EC in comparison to nicotine replacement patches (NRP) in smokers following 12 weeks of smoking cessation support with NHSGG\&C Smokefree Community Services. We hypothesise that both EC and NRP users will experience improvements in cardiovascular and pulmonary function; but the effects may be less pronounced in EC users.
The data generated from the pilot study will be invaluable for sample size and power estimation towards the development of a larger scale study. If the data generated from such a trial demonstrate that EC have short-term cardiovascular and pulmonary health effects, this may reduce tobacco associated morbidity and mortality, improve patient care and minimise NHS healthcare costs, and lead to the development of long term studies.
- Conditions
- Smoking, Tobacco
- Being tested
- Electron Cigarette, Nicotine Replacement Patch
- Keywords
- electronic cigarettes, cardiovascular, nicotine replacement patches
- Medical subject headings
- Tobacco Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electron CigaretteDevice
Also called Smokemax Power e-cigarette
Blended Tobacco flavour, 18mg/ml
Nicotine Replacement PatchDevice
Also called NiQuitin
NiQuitin 21mg
| Study group | Role | What they receive |
|---|---|---|
| Electronic Cigarettes | Other | Participants wishing to quit tobacco smoking have an equal chance of being assigned to the electronic cigarette arm. They are supplied with a second generation e-cigarette to support their quit attempt with standard of care once weekly support sessions from NHS smoking cessation services. Receives: Device: Electron Cigarette |
| Nicotine replacement patches | Other | Participants wishing to quit tobacco smoking have an equal chance of being assigned to the nicotine replacement patch arm (standard care). They are supplied with a second generation e-cigarette to support their quit attempt with standard of care once weekly support sessions from NHS smoking cessation services. Receives: Device: Nicotine Replacement Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endothelial function as assessed by flow mediated dilation
Change in endothelial function as assessed by flow mediated dilation
Measured: 12 weeks
Secondary outcomes (5)
Changes in respiratory function assessed through pulmonary function tests
Changes in respiratory function assessed through pulmonary function tests
Measured: 12 weeks
Changes in endothelial function assessed by Endo-PAT2000, a non-invasive technique
Changes in endothelial function assessed by Endo-PAT2000, a non-invasive technique
Measured: 12 weeks
• Changes in cardiovascular parameters through non-invasive haemodynamic measurements
- Changes in cardiovascular parameters through non-invasive haemodynamic measurements
Measured: 12 weeks
• Changes in cardiovascular risk factor profile as assess through biomarkers markers of inflammation
- Changes in cardiovascular risk factor profile as assess through biomarkers markers of inflammation
Measured: 12 weeks
• Changes in endothelial micoparticles
- Changes in endothelial micoparticles
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 posted2 Dec 2017
- Study start17 Dec 2016
- Primary completionJul 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, TobaccoStudies 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
- Single group
- Model description
- E-cigarette versus nicotine replacement patches
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Delles, MBChB PhD, Study chair, Glasgow University and NHS GGC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358953
- Sponsor's protocol ID
- GN16CH051
- Acronym
- VAPOUR
- Status last verified
- Sep 2018
- First submitted
- 27 Nov 2017
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiovascular Impacts of Electronic Cigarettes to the Use of Nicotine Replacement Patches
- ClinicalTrials.gov ID
- NCT03358953
- Acronym / sponsor ID
- VAPOUR / GN16CH051
- Conditions
- Smoking, Tobacco
- Keywords
- electronic cigarettes, cardiovascular, nicotine replacement patches
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- 17 Dec 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 2 Dec 2017 (actual)
- 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.
In Scotland tobacco-related illnesses account for in excess of 56,000 hospital admissions and a quarter of deaths each year. The resultant financial impact on NHS Scotland is over £300 million per annum. To minimise the clinical and financial burden of tobacco on national healthcare systems, Scotland's tobacco control strategy aims to create a "tobacco-free" generation by 2034, with the prevalence of smoking in the adult population reduced to ≤5 %. The multifaceted approach focuses upon tobacco prevention, protection and cessation.
In relation to smoking cessation, the use of EC has exponentially increased since 2011, and EC are presently the most popular nicotine replacement product used in England. The Public Health England (PHE) Report published in August 2015 advocates the use of EC when other smoking cessation aids have failed.
Detailed description
Tobacco smoking (TS) remains a major health challenge for people in Scotland. EC are presently the most popular nicotine replacement product used in England. Recently NHS Greater Glasgow and Clyde (NHSGGC) have, like other Health Boards and Trusts in the UK, lifted the ban on ECs on hospital grounds. This decision has been based on recent evidence that ECs appear to be less harmful when compared to TS but it is acknowledged that the short- and long-term sequelae of ECs remain unknown. Systematic research focusing on the effectiveness of ECs on cardiovascular and pulmonary phenotypes is urgently needed.
The VAPOUR pilot study is a randomised control trial (RCT) investigating the short-term cardiorespiratory effects of EC in comparison to nicotine replacement patches (NRP) in smokers following 12 weeks of smoking cessation support with NHSGG\&C Smokefree Community Services. We hypothesise that both EC and NRP users will experience improvements in cardiovascular and pulmonary function; but the effects may be less pronounced in EC users.
The data generated from the pilot study will be invaluable for sample size and power estimation towards the development of a larger scale study. If the data generated from such a trial demonstrate that EC have short-term cardiovascular and pulmonary health effects, this may reduce tobacco associated morbidity and mortality, improve patient care and minimise NHS healthcare costs, and lead to the development of long term studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- E-cigarette versus nicotine replacement patches
| Arm | Type | Receives |
|---|---|---|
| Electronic Cigarettes | Other | Device: Electron CigaretteParticipants wishing to quit tobacco smoking have an equal chance of being assigned to the electronic cigarette arm. They are supplied with a second generation e-cigarette to support their quit attempt with standard of care once weekly support sessions from NHS smoking cessation services. |
| Nicotine replacement patches | Other | Device: Nicotine Replacement PatchParticipants wishing to quit tobacco smoking have an equal chance of being assigned to the nicotine replacement patch arm (standard care). They are supplied with a second generation e-cigarette to support their quit attempt with standard of care once weekly support sessions from NHS smoking cessation services. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged between 18-65 years and wish to stop smoking. Smoker of at least 1-15 tobacco cigarette (TC) per day for ≥ six months Committed to attending weekly support sessions with NHSGGC Smokefree Services Must be willing to stop smoking tobacco cigarettes with the use of either nicotine replacement patches or an electronic cigarette with nicotine containing e-liquid.
Key exclusion criteria (8 listed)
- Breastfeeding or pregnancy Use of EC or NRP within the past three months Uncontrolled hypertension - Blood pressure ≥165/95 mmHg
- Unstable angina, heart failure New York Heart Association (NYHA) Functional Classification classes III - IV Recent stroke, myocardial infarction, coronary artery bypass graft or percutaneous coronary angiogram within the last 3 months.
- Established renal disease defined as eGFR <45 Established history of peripheral vascular disease Established history of Chronic Obstructive Pulmonary Disease. Illicit drug use Severe concurrent medical condition that would prevent participation in study procedures or malignant neoplasm or with life expectancy ≤ 3 months.
- Major depressive illness or other psychiatric conditions. Participants who decline participation in the study or who are unable to provide informed consent
- History of allergies to active substances, excipients or delivery device (patch) in NRP or EC
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 |
|---|---|---|
| Electron CigaretteAlso: Smokemax Power e-cigaretteBlended Tobacco flavour, 18mg/ml | Device | Electronic Cigarettes |
| Nicotine Replacement PatchAlso: NiQuitinNiQuitin 21mg | Device | Nicotine replacement patches |
Primary outcome
Change in endothelial function as assessed by flow mediated dilation
Time frame: 12 weeks
Change in endothelial function as assessed by flow mediated dilation
5 secondary outcomes
Changes in respiratory function assessed through pulmonary function tests
Time frame: 12 weeks
Changes in endothelial function assessed by Endo-PAT2000, a non-invasive technique
Time frame: 12 weeks
• Changes in cardiovascular parameters through non-invasive haemodynamic measurements
Time frame: 12 weeks
• Changes in cardiovascular risk factor profile as assess through biomarkers markers of inflammation
Time frame: 12 weeks
• Changes in endothelial micoparticles
Time frame: 12 weeks
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 18 Sep 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.
Christian Delles, MBChB PhD study chair
Glasgow University and NHS GGC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electron Cigarette and Nicotine Replacement Patch in people with Smoking, Tobacco, run by NHS Greater Glasgow and Clyde at 1 site 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 1 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 18 Sep 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 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?
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 endothelial function as assessed by flow mediated dilation (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 18 Sep 2018.