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

A Randomised, Parallel Group, Multi-centre Study to Evaluate the Safety Profile of the ITG EVP G1 Product

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: E-vapour product; Other: Conventional cigarette

• Study Type: Interventional
• Enrollment (Actual): 408
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Leeds, England, United Kingdom, LS2 9HL
      • Covance Clinical Research Unit
  • Wales
    • Merthyr Tydfil, Wales, United Kingdom, CF48 4DR
      • Simbec Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: e-vapour product (EVP); Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).	Other: E-vapour product; Smokers of conventional cigarettes who switch to use an e-vapour product.
Active Comparator: Conventional cigarette (CC); Subjects who continue smoking their usual conventional cigarette (CC) brand.	Other: Conventional cigarette; Smokers of conventional cigarettes who continue smoking conventional cigarettes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Frequency of adverse events	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exhaled Carbon Monoxide	Level of exhaled carbon monoxide at Week 12	12 weeks

Collaborators and Investigators

• Sponsor: Imperial Brands PLC
• Investigators: Principal Investigator: Jim Bush, MD, Covance Clinical Research Unit, Springfield House, Hyde Street, Leeds LS2 9LH, UK; Principal Investigator: Girish Sharma, MD, Simbec Research, Merthyr Tydfil, CF48 4DR, UK

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 7, 2014

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ITG EVP G1 S2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED