Trial Outcomes & Findings for User Acceptability of a Nicotine Lactate Delivery System (P3L) (NCT NCT02643693)
NCT ID: NCT02643693
Last Updated: 2019-08-01
Results Overview
For each ad libitum use session (P3L, VUSE, and CC), change from baseline plasma concentration of Nicotine/Cotinine was measured from two blood samples collected before product use (to provide baseline measures) and from two blood samples collected following product use (to show change from baseline).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Measured at 15 minutes and 5 minutes prior to each 3 hour product use to provide baseline measures, then at 15 minutes and 30 minutes after product use period to show change from baseline.
Results posted on
2019-08-01
Participant Flow
Study initiated (1st subject screened): 16 November 2015 A demonstration of the P3L system and the VUSE e-cigarette system was given to the subjects.
Enrolled population = 24 subjects All enrolled subjects met all of the inclusion and none of the exclusion criteria for the study. Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
Participant milestones
| Measure |
P3L/Vuse/CC Product Exposure
Subjects followed a sequence of product exposure comprised of P3L; VUSE; CC.
|
P3L/CC/Vuse Product Exposure
Subjects followed a sequence of product exposure comprised of P3L; CC; Vuse.
|
Vuse/CC/P3L Product Exposure
Subjects followed a sequence of product exposure comprised of Vuse; CC; P3L.
|
Vuse/P3L/CC Product Exposure
Subjects followed a sequence of product exposure comprised of Vuse; P3L; CC.
|
CC/P3L/Vuse Product Exposure
Subjects followed a sequence of product exposure comprised of CC; P3L; Vuse.
|
CC/Vuse/P3L Product Exposure
Subjects followed a sequence of product exposure comprised of the three products (CC; Vuse; P3L).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
2
|
2
|
3
|
4
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
P3L/Vuse/CC Product Exposure
Subjects followed a sequence of product exposure comprised of P3L; VUSE; CC.
|
P3L/CC/Vuse Product Exposure
Subjects followed a sequence of product exposure comprised of P3L; CC; Vuse.
|
Vuse/CC/P3L Product Exposure
Subjects followed a sequence of product exposure comprised of Vuse; CC; P3L.
|
Vuse/P3L/CC Product Exposure
Subjects followed a sequence of product exposure comprised of Vuse; P3L; CC.
|
CC/P3L/Vuse Product Exposure
Subjects followed a sequence of product exposure comprised of CC; P3L; Vuse.
|
CC/Vuse/P3L Product Exposure
Subjects followed a sequence of product exposure comprised of the three products (CC; Vuse; P3L).
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Adherence Issues
|
2
|
0
|
1
|
0
|
0
|
1
|
Baseline Characteristics
User Acceptability of a Nicotine Lactate Delivery System (P3L)
Baseline characteristics by cohort
| Measure |
P3L/VUSE/CC Product Exposure
n=22 Participants
Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
|
|---|---|
|
Age, Customized
<=19 years
|
0 Participants
n=99 Participants
|
|
Age, Customized
Between 19 and 65 years
|
22 Participants
n=99 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Measured at 15 minutes and 5 minutes prior to each 3 hour product use to provide baseline measures, then at 15 minutes and 30 minutes after product use period to show change from baseline.Population: All the subjects who gave informed consent and completed all three ad libitum use sessions, without major protocol deviations.
For each ad libitum use session (P3L, VUSE, and CC), change from baseline plasma concentration of Nicotine/Cotinine was measured from two blood samples collected before product use (to provide baseline measures) and from two blood samples collected following product use (to show change from baseline).
Outcome measures
| Measure |
P3L Product Exposure
n=16 Participants
Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
|
VUSE Product Exposure
n=16 Participants
Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
|
CC Product Exposure
n=16 Participants
Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
|
|---|---|---|---|
|
Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session.
Baseline (Average) before session: Nicotine
|
1.7621 (ng/mL)
Interval 1.1308 to 2.7459
|
2.4113 (ng/mL)
Interval 1.8529 to 3.1378
|
1.9446 (ng/mL)
Interval 1.5375 to 2.4594
|
|
Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session.
Change from Baseline after session: Nicotine
|
5.5571 (ng/mL)
Interval 3.5802 to 8.6255
|
7.3425 (ng/mL)
Interval 4.7138 to 11.4371
|
17.1821 (ng/mL)
Interval 13.7633 to 21.45
|
|
Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session.
Baseline (Average) before session: Cotinine
|
182.554 (ng/mL)
Interval 148.073 to 225.065
|
187.559 (ng/mL)
Interval 147.914 to 237.828
|
199.547 (ng/mL)
Interval 161.636 to 246.351
|
|
Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session.
Change from Baseline after session: Cotinine
|
15.222 (ng/mL)
Interval 10.116 to 22.905
|
11.163 (ng/mL)
Interval 5.523 to 22.561
|
33.888 (ng/mL)
Interval 24.004 to 47.842
|
PRIMARY outcome
Timeframe: QSU-brief questionnaire completed before product use session, then at 60 mins, 120 mins, and 180 mins after starting each product use session.Population: All the subjects who gave informed consent and completed all three ad libitum use sessions, without major protocol deviations.
The QSU-Brief questionnaire is an instrument used to measure urge to smoke. Subjects were asked to respond to 10 questions, scored from 1 to 7 on a 7-point scale. A score of 1 on this scale indicates a very low urge to smoke, while a score of 7 indicates a very high urge to smoke. Subjects were asked to complete the questionnaire before, during, and after each ad libitum product use session. (P3L, VUSE, and Subjects' Own Brand of Non-menthol CC). Two factor scores and a total score were derived. Factor 1 represents the desire and intention to smoke with smoking perceived as rewarding, while Factor 2 represents an anticipation of relief from negative effect with an urgent desire to smoke. Products were compared over all timepoints using a repeated measure model using values after t0. The model adjusted for baseline value, sequence, and period with repeated measure over time and a random effect in subjects. Adjusted mean over all timepoints, for each timepoint, were estimated.
Outcome measures
| Measure |
P3L Product Exposure
n=16 Participants
Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
|
VUSE Product Exposure
n=16 Participants
Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
|
CC Product Exposure
n=16 Participants
Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
|
|---|---|---|---|
|
Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
Total Score - Over all timepoints
|
3.86 score on a scale
Interval 3.36 to 4.36
|
3.08 score on a scale
Interval 2.58 to 3.58
|
1.93 score on a scale
Interval 1.43 to 2.42
|
|
Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
Total Score - t0 + 60mins
|
4.02 score on a scale
Interval 3.51 to 4.52
|
3.24 score on a scale
Interval 2.74 to 3.74
|
2.09 score on a scale
Interval 1.58 to 2.59
|
|
Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
Total Score - t0 + 120mins
|
3.84 score on a scale
Interval 3.33 to 4.36
|
3.07 score on a scale
Interval 2.56 to 3.58
|
1.91 score on a scale
Interval 1.4 to 2.42
|
|
Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
Total Score - t0 + 180mins
|
3.71 score on a scale
Interval 3.2 to 4.23
|
2.94 score on a scale
Interval 2.42 to 3.45
|
1.78 score on a scale
Interval 1.27 to 2.29
|
|
Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
Factor 1 - Over all timepoints
|
4.97 score on a scale
Interval 4.39 to 5.54
|
4.11 score on a scale
Interval 3.54 to 4.68
|
2.15 score on a scale
Interval 1.58 to 2.73
|
|
Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
Factor 1 - t0 + 60mins
|
4.87 score on a scale
Interval 4.28 to 5.46
|
4.48 score on a scale
Interval 3.89 to 5.06
|
2.53 score on a scale
Interval 1.94 to 3.12
|
|
Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
Factor 1 - t0 + 120mins
|
4.99 score on a scale
Interval 4.33 to 5.64
|
4.11 score on a scale
Interval 3.46 to 4.77
|
2.08 score on a scale
Interval 1.42 to 2.74
|
|
Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
Factor 1 - t0 + 180mins
|
5.05 score on a scale
Interval 4.43 to 5.66
|
3.74 score on a scale
Interval 3.13 to 4.35
|
1.84 score on a scale
Interval 1.23 to 2.46
|
|
Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
Factor 2 - Over all timepoints
|
2.85 score on a scale
Interval 2.34 to 3.36
|
2.15 score on a scale
Interval 1.64 to 2.66
|
1.60 score on a scale
Interval 1.1 to 2.11
|
|
Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
Factor 2 - t0 + 60mins
|
2.95 score on a scale
Interval 2.43 to 3.48
|
2.25 score on a scale
Interval 1.73 to 2.78
|
1.71 score on a scale
Interval 1.19 to 2.23
|
|
Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
Factor 2 - t0 + 120mins
|
2.84 score on a scale
Interval 2.33 to 3.35
|
2.14 score on a scale
Interval 1.63 to 2.65
|
1.59 score on a scale
Interval 1.09 to 2.1
|
|
Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
Factor 2 - t0 + 180mins
|
2.76 score on a scale
Interval 2.24 to 3.28
|
2.06 score on a scale
Interval 1.54 to 2.58
|
1.51 score on a scale
Interval 1.0 to 2.03
|
Adverse Events
P3L Product
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
VUSE Product
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
CC Product
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
P3L Product
n=21 participants at risk
Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
|
VUSE Product
n=19 participants at risk
Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
|
CC Product
n=19 participants at risk
Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
19.0%
4/21 • Number of events 4 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
15.8%
3/19 • Number of events 3 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
Nervous system disorders
Disturbance In Attention
|
14.3%
3/21 • Number of events 4 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
15.8%
3/19 • Number of events 3 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.1%
8/21 • Number of events 10 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
31.6%
6/19 • Number of events 8 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
19.0%
4/21 • Number of events 4 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
19.0%
4/21 • Number of events 4 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
1/21 • Number of events 2 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
General disorders
Feeling Jittery
|
23.8%
5/21 • Number of events 5 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
21.1%
4/19 • Number of events 4 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
General disorders
Chest Discomfort
|
0.00%
0/21 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
General disorders
Chest Pain
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
General disorders
Unevaluable Event
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
Gastrointestinal disorders
Dry Mouth
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
15.8%
3/19 • Number of events 3 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • Number of events 2 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/21 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
10.5%
2/19 • Number of events 3 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
Cardiac disorders
Palpitations
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
4.8%
1/21 • Number of events 1 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
0.00%
0/19 • Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.
The safety was assessed in the safety population, consisting of all randomized subjects who gave informed consent and had exposure to at least one of the investigational products as part of the study (including P3L system, the VUSE e-cigarette system or CC). Overall safety population = 22 subjects; P3L exposure = 21 subjects; VUSE exposure = 19 subjects; CC exposure = 19 subjects.
|
Additional Information
Christelle Haziza, PhD
Philip Morris Products S.A.
Phone: +41 (58) 242 11 11
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements. The Intellectual Property rights and research results from the present study belong to the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER