N/A
N=408
A Study to Evaluate the Safety Profile of an e-Vapour Product
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02029196 ↗Enrolled (actual)
408
Serious AEs
1.2%
Results posted
Mar 2017
Primary outcome: Primary: Adverse Events — 1.60; 0.79 percentage of adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- E-vapour product (Other); Conventional cigarette (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Imperial Brands PLC
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
1.60; 0.79 | — |
| SECONDARY Exhaled Carbon Monoxide |
8.99; 23.1 | — |
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.
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02029196). 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.