Trial Outcomes & Findings for A Study to Evaluate the Safety of Electronic Vapor Products for 2 Years (NCT NCT02143310)

Results Overview

Sitting systolic blood pressure (mmHg)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

209 participants

Primary outcome timeframe

24 months

Results posted on

2019-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	EVP Users Subject who switch to use the electronic vapour product (EVP) for up to 2 years EVP
Overall Study STARTED	209
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	107

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EVP Users n=209 Participants Subjects who switch to use the EVP for up to 2 years EVP
Age, Continuous	36.6 years STANDARD_DEVIATION 10.2 • n=209 Participants
Sex: Female, Male Female	94 Participants n=209 Participants
Sex: Female, Male Male	115 Participants n=209 Participants
Exhaled carbon monoxide (CO)	13.6 ppm STANDARD_DEVIATION 11.1 • n=209 Participants
Carboxyhemoglobin	5.09 Percent of total hemoglobin STANDARD_DEVIATION 2.04 • n=209 Participants
HDL cholesterol	1.41 mmol/L n=209 Participants
Biomarkers of exposure to nicotine	8.39 mg STANDARD_DEVIATION 7.19 • n=209 Participants
Level of white blood cells	7.3 G/L n=209 Participants

PRIMARY outcome

Timeframe: 24 months

Sitting systolic blood pressure (mmHg)

Outcome measures

Outcome measures
Measure	EVP Users n=102 Participants Subjects who use the EVP EVP
Blood Pressure	122.4 mmHg Standard Deviation 11.1

PRIMARY outcome

Timeframe: 24 months

In electrocardiography, the PR interval is the period that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex. Variations in the PR interval can be associated with certain medical conditions.

Outcome measures

Outcome measures
Measure	EVP Users n=102 Participants Subjects who use the EVP EVP
Electrocardiogram (ECG): PR Interval	152.3 ms Standard Deviation 18.7

PRIMARY outcome

Timeframe: 24 months

Forced Vital Capacity (FVC)

Outcome measures

Outcome measures
Measure	EVP Users n=102 Participants Subjects who use the EVP EVP
Lung Function Tests	4.369 Liters Standard Deviation 1.007

PRIMARY outcome

Timeframe: 24 months

High density lipoprotein (HDL) cholesterol, change from baseline (BL)

Outcome measures

Outcome measures
Measure	EVP Users n=102 Participants Subjects who use the EVP EVP
Clinical Laboratory Parameters	-0.03 mmol/L Interval -0.08 to 0.02

SECONDARY outcome

Timeframe: 24 Months

Nicotine withdrawal symptoms were measured using the revised Minnesota Nicotine Withdrawal Scale (MWS-R) questionnaire. Extended total scores were used, i.e. the sum of the scores of all 15 questions of the questionnaire. Symptoms (e.g. angry, irritable, frustrated, depressed, restless, insomnia) were rated from 0 (none) to 4 (severe). Extended total scores may range from 0 to a maximum of 60.

Outcome measures

Outcome measures
Measure	EVP Users n=102 Participants Subjects who use the EVP EVP
Nicotine Withdrawal Symptoms	3.3 score on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: 24 months

The exposure to nicotine was measured by quantifying the change from BL in the amount of nicotine equivalents excreted in urine in 24-hours (AE24h).

Outcome measures

Outcome measures
Measure	EVP Users n=102 Participants Subjects who use the EVP EVP
Biomarkers of Exposure to Nicotine	0.85 mg Interval -0.17 to 1.88

SECONDARY outcome

Timeframe: 24 months

Change from BL in the level of white blood cells.

Outcome measures

Outcome measures
Measure	EVP Users n=102 Participants Subjects who use the EVP EVP
Biomarkers of Effect	-0.31 G/L Interval -0.62 to 0.0

Adverse Events

EVP Users

Serious events: 7 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EVP Users n=209 participants at risk Subjects who use the EVP EVP
Gastrointestinal disorders Acute pancreatitis	0.48% 1/209 • 24 months
Injury, poisoning and procedural complications Concussion	0.48% 1/209 • 24 months
Nervous system disorders Right occipital stroke	0.48% 1/209 • 24 months
Pregnancy, puerperium and perinatal conditions Spontaneous abortion	0.96% 2/209 • 24 months
Infections and infestations Pneumonia	0.48% 1/209 • 24 months
Injury, poisoning and procedural complications Joint injury	0.48% 1/209 • 24 months

Other adverse events

Other adverse events
Measure	EVP Users n=209 participants at risk Subjects who use the EVP EVP
Nervous system disorders Headache	28.7% 60/209 • 24 months
Infections and infestations Nasopharyngitis	28.7% 60/209 • 24 months
Infections and infestations Influenza	8.6% 18/209 • 24 months
Infections and infestations Urinary tract infection	5.7% 12/209 • 24 months
Respiratory, thoracic and mediastinal disorders Sore throat	19.6% 41/209 • 24 months
Respiratory, thoracic and mediastinal disorders Cough	16.7% 35/209 • 24 months
Psychiatric disorders Nicotine dependence	12.0% 25/209 • 24 months
Gastrointestinal disorders Toothache	8.1% 17/209 • 24 months
Gastrointestinal disorders Nausea	5.3% 11/209 • 24 months
Musculoskeletal and connective tissue disorders Back pain	7.2% 15/209 • 24 months
Immune system disorders Seasonal allergy	6.7% 14/209 • 24 months

Additional Information

Tanvir Walele

FontemVentures

Phone: 01779337589

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place