N/A
N=209
A Study to Evaluate the Safety of Electronic Vapor Products for 2 Years
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02143310 ↗Enrolled (actual)
209
Serious AEs
3.4%
Results posted
Jul 2019
Primary outcome: Primary: Blood Pressure — 122.4 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EVP (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Fontem Ventures BV
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Pressure |
122.4 | — |
| PRIMARY Electrocardiogram (ECG): PR Interval |
152.3 | — |
| PRIMARY Lung Function Tests |
4.369 | — |
| PRIMARY Clinical Laboratory Parameters |
-0.03 | — |
| SECONDARY Nicotine Withdrawal Symptoms |
3.3 | — |
| SECONDARY Biomarkers of Exposure to Nicotine |
0.85 | — |
| SECONDARY Biomarkers of Effect |
-0.31 | — |
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.
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02143310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.