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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02029196
Other study ID # ITG EVP G1 S2
Secondary ID
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


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
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