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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02029196
• Other study ID #: ITG EVP G1 S2
• Status: Active, not recruiting
• Phase: N/A
• First received: December 19, 2013
• Last updated: September 6, 2016
• Start date: December 2013
• Est. completion date: November 2016

Study information

• Verified date: September 2016
• Source: Imperial Tobacco Group PLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: South East Wales Research Ethics Committee
• Study type: Interventional

Clinical Trial 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 and tolerability of an e-vapour product.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• E-vapour product

• Conventional cigarette

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit	Leeds	England
United Kingdom	Simbec Research	Merthyr Tydfil	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Imperial Tobacco Group PLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital signs		Up to 12 weeks	Yes
Primary	ECG		Up to 12 weeks	Yes
Primary	Lung Function Testing		Up to 12 weeks	Yes
Primary	Clinical laboratory parameters		Up to 12 weeks	Yes
Secondary	Craving and withdrawal symptoms		Up to 12 weeks	No
Secondary	Carboxyhaemoglobin		Up to 12 weeks	No
Secondary	High-density lipoprotein cholesterol		Up to 12 weeks	No