Overview

This trial is active, not recruiting.

Condition healthy volunteers
Treatment evp
Sponsor Fontem Ventures BV
Start date May 2014
End date July 2017
Trial size 420 participants
Trial identifier NCT02143310, EVP G1 S3

Summary

Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes 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 over two years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
Subject who use the EVP
evp

Primary Outcomes

Measure
Change from baseline (BL) in blood pressure
time frame: BL, 1Month (Mo), 3Mo, 6Mo, 12Mo, 18Mo and end of study (EOS)
Change from BL in electrocardiogram (ECG)
time frame: BL, 1Mo, 3Mo, 6Mo, 12Mo, 18Mo and EOS
Change from BL in lung function tests
time frame: BL, 1Mo, 3Mo, 6Mo, 12Mo, 18Mo and EOS
Change from BL in clinical laboratory parameters
time frame: BL, 1Mo, 3Mo, 6Mo, 12Mo, 18Mo and EOS

Secondary Outcomes

Measure
Change from BL in craving and withdrawal symptoms
time frame: BL, 1Mo, 2Mo, 3Mo, 6Mo, 9Mo, 12Mo, 15Mo, 18Mo, 21Mo and EOS
Change from BL in biomarkers of exposure
time frame: BL, 1Mo, 2Mo, 3Mo, 6Mo, 9Mo, 12Mo, 15Mo, 18Mo, 21Mo and EOS
Change from BL in biomarkers of effect
time frame: BL, 1Mo, 2Mo, 3Mo, 6Mo, 9Mo, 12Mo, 15Mo, 18Mo, 21Mo and EOS

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

Inclusion Criteria: - Subject who participated in the EVP G1 S2 study (S2) - Willingness to use the EVP provided by the sponsor for two years as the only nicotine containing product - No clinically significant abnormalities during the S2 study Exclusion Criteria: - Subjects who have used nicotine replacement therapy during the S2 study - Subjects with relevant illness history - 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.

Additional Information

Official title A Multi-Centre Study to Evaluate the Safety of Use of Electronic Vapour Products for Two Years
Principal investigator Jim Bush, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Fontem Ventures BV.