A Study to Evaluate the Safety Profile of an e-Vapour Product

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: E-vapour product; Other: Conventional cigarette

• Registration Number: NCT02029196
• Lead Sponsor: Imperial Brands PLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2016-11-23
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-31
• Last Update Submitted: 2017-01-31
• Results First Posted: 2017-03-21
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
e-vapour product (EVP)	E-vapour product	Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
Conventional cigarette (CC)	Conventional cigarette	Subjects who continue smoking their usual conventional cigarette (CC) brand.

Primary Outcome Measures

Name	Time	Method
Adverse Events	12 weeks	Frequency of adverse events

Secondary Outcome Measures

Name	Time	Method
Exhaled Carbon Monoxide	12 weeks	Level of exhaled carbon monoxide at Week 12

Trial Locations

Locations (2)

Simbec Research; 🇬🇧 Merthyr Tydfil, Wales, United Kingdom

Covance Clinical Research Unit; 🇬🇧 Leeds, England, United Kingdom