Trial Outcomes & Findings for A Study to Evaluate the Safety Profile of an e-Vapour Product (NCT NCT02029196)
NCT ID: NCT02029196
Last Updated: 2017-03-21
Results Overview
Frequency of adverse events
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
408 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-03-21
Participant Flow
Participant milestones
| Measure |
E-vapour Product (EVP)
Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
|
Conventional Cigarette (CC)
Subjects who continue smoking their usual conventional cigarette (CC) brand.
|
|---|---|---|
|
Overall Study
STARTED
|
306
|
102
|
|
Overall Study
COMPLETED
|
286
|
101
|
|
Overall Study
NOT COMPLETED
|
20
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety Profile of an e-Vapour Product
Baseline characteristics by cohort
| Measure |
E-vapour Product (EVP)
n=306 Participants
Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
|
Conventional Cigarette (CC)
n=102 Participants
Subjects who continue smoking their usual conventional cigarette (CC) brand.
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
35.1 years
STANDARD_DEVIATION 10.6 • n=107 Participants
|
34.3 years
STANDARD_DEVIATION 10.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
182 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
168 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
226 Participants
n=206 Participants
|
|
Exhaled Carbon Monoxide (eCO)
|
15.8 parts per million (ppm)
STANDARD_DEVIATION 6.3 • n=99 Participants
|
16.7 parts per million (ppm)
STANDARD_DEVIATION 7.3 • n=107 Participants
|
16.0 parts per million (ppm)
STANDARD_DEVIATION 6.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: All subjects who used the study product at least once.
Frequency of adverse events
Outcome measures
| Measure |
E-vapour Product (EVP)
n=306 Participants
Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
|
Conventional Cigarette (CC)
n=102 Participants
Subjects who continue smoking their usual conventional cigarette (CC) brand.
|
|---|---|---|
|
Adverse Events
|
1.60 percentage of adverse events
Interval 1.55 to 1.65
|
0.79 percentage of adverse events
Interval 0.66 to 0.92
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Measure performed on subjects who completed the 12-week study (286 in the e-vapour product arm and 100 in the conventional cigarette arm).
Level of exhaled carbon monoxide at Week 12
Outcome measures
| Measure |
E-vapour Product (EVP)
n=286 Participants
Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
|
Conventional Cigarette (CC)
n=100 Participants
Subjects who continue smoking their usual conventional cigarette (CC) brand.
|
|---|---|---|
|
Exhaled Carbon Monoxide
|
8.99 parts per million (ppm)
Standard Deviation 6.33
|
23.1 parts per million (ppm)
Standard Deviation 10.3
|
Adverse Events
E-vapour Product (EVP)
Serious events: 5 serious events
Other events: 271 other events
Deaths: 0 deaths
Conventional Cigarette (CC)
Serious events: 0 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E-vapour Product (EVP)
n=306 participants at risk
Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
|
Conventional Cigarette (CC)
n=102 participants at risk
Subjects who continue smoking their usual conventional cigarette (CC) brand.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Wound
|
0.33%
1/306 • Number of events 1 • 12 weeks
|
0.00%
0/102 • 12 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.33%
1/306 • Number of events 1 • 12 weeks
|
0.00%
0/102 • 12 weeks
|
|
Nervous system disorders
Headache
|
0.33%
1/306 • Number of events 1 • 12 weeks
|
0.00%
0/102 • 12 weeks
|
|
Infections and infestations
Lobar pneumonia
|
0.33%
1/306 • Number of events 1 • 12 weeks
|
0.00%
0/102 • 12 weeks
|
|
Cardiac disorders
Arrhythmia
|
0.33%
1/306 • Number of events 1 • 12 weeks
|
0.00%
0/102 • 12 weeks
|
Other adverse events
| Measure |
E-vapour Product (EVP)
n=306 participants at risk
Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
|
Conventional Cigarette (CC)
n=102 participants at risk
Subjects who continue smoking their usual conventional cigarette (CC) brand.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
27.8%
85/306 • Number of events 119 • 12 weeks
|
8.8%
9/102 • Number of events 9 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.0%
52/306 • Number of events 62 • 12 weeks
|
7.8%
8/102 • Number of events 9 • 12 weeks
|
|
Nervous system disorders
Headache
|
47.4%
145/306 • Number of events 372 • 12 weeks
|
33.3%
34/102 • Number of events 72 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
34/306 • Number of events 36 • 12 weeks
|
7.8%
8/102 • Number of events 9 • 12 weeks
|
|
Psychiatric disorders
Desire to smoke
|
27.5%
84/306 • Number of events 86 • 12 weeks
|
12.7%
13/102 • Number of events 13 • 12 weeks
|
|
General disorders
Irritability
|
10.8%
33/306 • Number of events 36 • 12 weeks
|
0.98%
1/102 • Number of events 1 • 12 weeks
|
|
Metabolism and nutrition disorders
Increased appetite
|
14.1%
43/306 • Number of events 43 • 12 weeks
|
0.98%
1/102 • Number of events 1 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place