A Randomised, Parallel Group, Multi-centre Study to Evaluate the Safety Profile of the ITG EVP G1 Product
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Imperial Brands PLC
- Enrollment
- 408
- Locations
- 2
- Primary Endpoint
- Adverse Events
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
e-vapour product (EVP)
Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
Intervention: E-vapour product (Other)
Conventional cigarette (CC)
Subjects who continue smoking their usual conventional cigarette (CC) brand.
Intervention: Conventional cigarette (Other)
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 12 weeks
Frequency of adverse events
Secondary Outcomes
- Exhaled Carbon Monoxide(12 weeks)