Trial Outcomes & Findings for Reduced Exposure to HPHC in Smokers Switching From Cigarettes to Different Versions of THS (NCT NCT05599451)
NCT ID: NCT05599451
Last Updated: 2024-09-20
Results Overview
Concentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
5 days
Results posted on
2024-09-20
Participant Flow
Participant milestones
| Measure |
Enrolled But Not Randomized
Subjects who were enrolled, but were not randomized to a study arm.
|
Cigarette
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the subject's preferred brand of regular (non-mentholated) cigarette between 06:30 AM and 11:00 PM.
(Every subject brought a sufficient number of unopened, single-brand packs of CIG for the entire confinement period.)
CIG: Subject's preferred brand of commercially available regular (non-mentholated) cigarettes. (Cigarettes are not provided by the study sponsor.)
|
THS Blade Device
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Blade device (using regular THS blade tobacco sticks) between 06:30 AM and 11:00 PM.
THS Blade device: Tobacco Heating System (THS) device with Blade technology for Blade tobacco stick use
|
THS Induction Mono Device
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mono device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mono device: Tobacco Heating System (THS) device with Induction technology (combined Charger-Holder device for Induction tobacco stick use).
|
THS Induction Mid Device
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mid device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mid device: Tobacco Heating System (THS) device with Induction technology (device with Induction stick Holder for Induction tobacco stick use and separate Charger).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
19
|
20
|
21
|
20
|
|
Overall Study
COMPLETED
|
0
|
19
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
11
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Enrolled But Not Randomized
Subjects who were enrolled, but were not randomized to a study arm.
|
Cigarette
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the subject's preferred brand of regular (non-mentholated) cigarette between 06:30 AM and 11:00 PM.
(Every subject brought a sufficient number of unopened, single-brand packs of CIG for the entire confinement period.)
CIG: Subject's preferred brand of commercially available regular (non-mentholated) cigarettes. (Cigarettes are not provided by the study sponsor.)
|
THS Blade Device
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Blade device (using regular THS blade tobacco sticks) between 06:30 AM and 11:00 PM.
THS Blade device: Tobacco Heating System (THS) device with Blade technology for Blade tobacco stick use
|
THS Induction Mono Device
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mono device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mono device: Tobacco Heating System (THS) device with Induction technology (combined Charger-Holder device for Induction tobacco stick use).
|
THS Induction Mid Device
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mid device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mid device: Tobacco Heating System (THS) device with Induction technology (device with Induction stick Holder for Induction tobacco stick use and separate Charger).
|
|---|---|---|---|---|---|
|
Overall Study
Not randomized
|
11
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Reduced Exposure to HPHC in Smokers Switching From Cigarettes to Different Versions of THS
Baseline characteristics by cohort
| Measure |
Cigarette
n=19 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the subject's preferred brand of regular (non-mentholated) cigarette between 06:30 AM and 11:00 PM.
(Every subject brought a sufficient number of unopened, single-brand packs of CIG for the entire confinement period.)
CIG: Subject's preferred brand of commercially available regular (non-mentholated) cigarettes. (Cigarettes are not provided by the study sponsor.)
|
THS Blade Device
n=20 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Blade device (using regular THS blade tobacco sticks) between 06:30 AM and 11:00 PM.
THS Blade device: Tobacco Heating System (THS) device with Blade technology for Blade tobacco stick use
|
THS Induction Mono Device
n=21 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mono device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mono device: Tobacco Heating System (THS) device with Induction technology (combined Charger-Holder device for Induction tobacco stick use).
|
THS Induction Mid Device
n=20 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mid device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mid device: Tobacco Heating System (THS) device with Induction technology (device with Induction stick Holder for Induction tobacco stick use and separate Charger).
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 9.51 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 10.96 • n=7 Participants
|
40.0 years
STANDARD_DEVIATION 11.77 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 9.19 • n=4 Participants
|
38.8 years
STANDARD_DEVIATION 10.29 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
BMI (at screening)
|
26.19 kg/m²
n=5 Participants
|
24.51 kg/m²
n=7 Participants
|
25.35 kg/m²
n=5 Participants
|
26.73 kg/m²
n=4 Participants
|
25.69 kg/m²
n=21 Participants
|
PRIMARY outcome
Timeframe: 5 daysConcentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
Outcome measures
| Measure |
Cigarette
n=19 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the subject's preferred brand of regular (non-mentholated) cigarette between 06:30 AM and 11:00 PM.
(Every subject brought a sufficient number of unopened, single-brand packs of CIG for the entire confinement period.)
CIG: Subject's preferred brand of commercially available regular (non-mentholated) cigarettes. (Cigarettes are not provided by the study sponsor.)
|
THS Blade Device
n=20 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Blade device (using regular THS blade tobacco sticks) between 06:30 AM and 11:00 PM.
THS Blade device: Tobacco Heating System (THS) device with Blade technology for Blade tobacco stick use
|
THS Induction Mono Device
n=21 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mono device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mono device: Tobacco Heating System (THS) device with Induction technology (combined Charger-Holder device for Induction tobacco stick use).
|
THS Induction Mid Device
n=20 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mid device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mid device: Tobacco Heating System (THS) device with Induction technology (device with Induction stick Holder for Induction tobacco stick use and separate Charger).
|
|---|---|---|---|---|
|
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
After 3 days
|
775.24 ng/mg creatinine
Interval 558.75 to 1075.61
|
190.61 ng/mg creatinine
Interval 146.36 to 248.24
|
199.11 ng/mg creatinine
Interval 167.67 to 236.45
|
200.33 ng/mg creatinine
Interval 158.43 to 253.31
|
|
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
Baseline
|
786.07 ng/mg creatinine
Interval 605.6 to 1020.32
|
674.08 ng/mg creatinine
Interval 478.57 to 949.46
|
781.63 ng/mg creatinine
Interval 611.65 to 998.85
|
765.28 ng/mg creatinine
Interval 579.16 to 1011.21
|
|
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
After 1 day
|
711.21 ng/mg creatinine
Interval 554.98 to 911.41
|
206.87 ng/mg creatinine
Interval 163.28 to 262.09
|
223.71 ng/mg creatinine
Interval 181.65 to 275.52
|
204.79 ng/mg creatinine
Interval 164.8 to 254.48
|
|
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
After 2 days
|
810.16 ng/mg creatinine
Interval 589.94 to 1112.57
|
235.60 ng/mg creatinine
Interval 185.92 to 298.56
|
235.20 ng/mg creatinine
Interval 190.35 to 290.62
|
231.39 ng/mg creatinine
Interval 187.62 to 285.39
|
|
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
After 4 days
|
921.78 ng/mg creatinine
Interval 715.95 to 1186.79
|
244.63 ng/mg creatinine
Interval 195.86 to 305.53
|
231.94 ng/mg creatinine
Interval 192.84 to 278.97
|
200.21 ng/mg creatinine
Interval 153.5 to 261.12
|
|
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
After 5 days
|
760.37 ng/mg creatinine
Interval 581.14 to 994.87
|
227.64 ng/mg creatinine
Interval 178.7 to 289.98
|
196.90 ng/mg creatinine
Interval 155.34 to 249.56
|
211.03 ng/mg creatinine
Interval 172.2 to 258.62
|
PRIMARY outcome
Timeframe: 5 daysConcentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
Outcome measures
| Measure |
Cigarette
n=19 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the subject's preferred brand of regular (non-mentholated) cigarette between 06:30 AM and 11:00 PM.
(Every subject brought a sufficient number of unopened, single-brand packs of CIG for the entire confinement period.)
CIG: Subject's preferred brand of commercially available regular (non-mentholated) cigarettes. (Cigarettes are not provided by the study sponsor.)
|
THS Blade Device
n=20 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Blade device (using regular THS blade tobacco sticks) between 06:30 AM and 11:00 PM.
THS Blade device: Tobacco Heating System (THS) device with Blade technology for Blade tobacco stick use
|
THS Induction Mono Device
n=21 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mono device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mono device: Tobacco Heating System (THS) device with Induction technology (combined Charger-Holder device for Induction tobacco stick use).
|
THS Induction Mid Device
n=20 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mid device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mid device: Tobacco Heating System (THS) device with Induction technology (device with Induction stick Holder for Induction tobacco stick use and separate Charger).
|
|---|---|---|---|---|
|
Concentration of 2-cyanoethyl Mercapturic Acid N-acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA)
Baseline
|
96.01 ng/mg creatinine
Interval 67.06 to 137.46
|
85.66 ng/mg creatinine
Interval 57.14 to 128.42
|
107.33 ng/mg creatinine
Interval 84.22 to 136.77
|
104.62 ng/mg creatinine
Interval 79.5 to 137.68
|
|
Concentration of 2-cyanoethyl Mercapturic Acid N-acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA)
After 1 day
|
100.15 ng/mg creatinine
Interval 76.73 to 130.71
|
27.81 ng/mg creatinine
Interval 17.19 to 45.01
|
38.17 ng/mg creatinine
Interval 30.22 to 48.22
|
32.93 ng/mg creatinine
Interval 25.54 to 42.46
|
|
Concentration of 2-cyanoethyl Mercapturic Acid N-acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA)
After 2 days
|
106.01 ng/mg creatinine
Interval 76.19 to 147.51
|
16.44 ng/mg creatinine
Interval 10.4 to 25.96
|
21.38 ng/mg creatinine
Interval 15.19 to 30.1
|
21.48 ng/mg creatinine
Interval 16.9 to 27.3
|
|
Concentration of 2-cyanoethyl Mercapturic Acid N-acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA)
After 3 days
|
108.76 ng/mg creatinine
Interval 78.01 to 151.63
|
13.31 ng/mg creatinine
Interval 8.02 to 22.12
|
16.85 ng/mg creatinine
Interval 11.93 to 23.81
|
18.09 ng/mg creatinine
Interval 14.2 to 23.05
|
|
Concentration of 2-cyanoethyl Mercapturic Acid N-acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA)
After 4 days
|
113.99 ng/mg creatinine
Interval 86.97 to 149.4
|
11.54 ng/mg creatinine
Interval 7.19 to 18.53
|
13.74 ng/mg creatinine
Interval 9.26 to 20.4
|
13.36 ng/mg creatinine
Interval 9.75 to 18.31
|
|
Concentration of 2-cyanoethyl Mercapturic Acid N-acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA)
After 5 days
|
108.64 ng/mg creatinine
Interval 81.43 to 144.96
|
12.20 ng/mg creatinine
Interval 7.6 to 19.58
|
13.34 ng/mg creatinine
Interval 8.8 to 20.22
|
15.95 ng/mg creatinine
Interval 12.48 to 20.38
|
PRIMARY outcome
Timeframe: 5 daysConcentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
Outcome measures
| Measure |
Cigarette
n=19 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the subject's preferred brand of regular (non-mentholated) cigarette between 06:30 AM and 11:00 PM.
(Every subject brought a sufficient number of unopened, single-brand packs of CIG for the entire confinement period.)
CIG: Subject's preferred brand of commercially available regular (non-mentholated) cigarettes. (Cigarettes are not provided by the study sponsor.)
|
THS Blade Device
n=20 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Blade device (using regular THS blade tobacco sticks) between 06:30 AM and 11:00 PM.
THS Blade device: Tobacco Heating System (THS) device with Blade technology for Blade tobacco stick use
|
THS Induction Mono Device
n=21 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mono device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mono device: Tobacco Heating System (THS) device with Induction technology (combined Charger-Holder device for Induction tobacco stick use).
|
THS Induction Mid Device
n=20 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mid device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mid device: Tobacco Heating System (THS) device with Induction technology (device with Induction stick Holder for Induction tobacco stick use and separate Charger).
|
|---|---|---|---|---|
|
Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
Baseline
|
2.08 ng/mg creatinine
Interval 1.38 to 3.14
|
2.09 ng/mg creatinine
Interval 1.39 to 3.12
|
1.37 ng/mg creatinine
Interval 0.77 to 2.43
|
2.64 ng/mg creatinine
Interval 1.92 to 3.63
|
|
Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
After 1 day
|
1.74 ng/mg creatinine
Interval 1.21 to 2.52
|
0.43 ng/mg creatinine
Interval 0.32 to 0.57
|
0.36 ng/mg creatinine
Interval 0.24 to 0.55
|
0.52 ng/mg creatinine
Interval 0.41 to 0.66
|
|
Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
After 2 days
|
2.19 ng/mg creatinine
Interval 1.46 to 3.29
|
0.14 ng/mg creatinine
Interval 0.11 to 0.18
|
0.15 ng/mg creatinine
Interval 0.11 to 0.19
|
0.16 ng/mg creatinine
Interval 0.13 to 0.2
|
|
Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
After 3 days
|
1.88 ng/mg creatinine
Interval 1.2 to 2.93
|
0.08 ng/mg creatinine
Interval 0.06 to 0.11
|
0.08 ng/mg creatinine
Interval 0.06 to 0.1
|
0.10 ng/mg creatinine
Interval 0.08 to 0.13
|
|
Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
After 4 days
|
2.01 ng/mg creatinine
Interval 1.32 to 3.05
|
0.08 ng/mg creatinine
Interval 0.06 to 0.1
|
0.09 ng/mg creatinine
Interval 0.07 to 0.11
|
0.09 ng/mg creatinine
Interval 0.07 to 0.11
|
|
Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
After 5 days
|
1.97 ng/mg creatinine
Interval 1.34 to 2.91
|
0.10 ng/mg creatinine
Interval 0.08 to 0.13
|
0.10 ng/mg creatinine
Interval 0.08 to 0.12
|
0.10 ng/mg creatinine
Interval 0.08 to 0.12
|
PRIMARY outcome
Timeframe: 5 daysConcentrations measured in urine, adjusted for creatinine, at Day 5. Geometric Least Squares means are provided for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
Outcome measures
| Measure |
Cigarette
n=19 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the subject's preferred brand of regular (non-mentholated) cigarette between 06:30 AM and 11:00 PM.
(Every subject brought a sufficient number of unopened, single-brand packs of CIG for the entire confinement period.)
CIG: Subject's preferred brand of commercially available regular (non-mentholated) cigarettes. (Cigarettes are not provided by the study sponsor.)
|
THS Blade Device
n=20 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Blade device (using regular THS blade tobacco sticks) between 06:30 AM and 11:00 PM.
THS Blade device: Tobacco Heating System (THS) device with Blade technology for Blade tobacco stick use
|
THS Induction Mono Device
n=21 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mono device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mono device: Tobacco Heating System (THS) device with Induction technology (combined Charger-Holder device for Induction tobacco stick use).
|
THS Induction Mid Device
n=20 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mid device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mid device: Tobacco Heating System (THS) device with Induction technology (device with Induction stick Holder for Induction tobacco stick use and separate Charger).
|
|---|---|---|---|---|
|
Concentration of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
After 4 days
|
133.05 pg/mg creatinine
Interval 94.47 to 187.38
|
34.49 pg/mg creatinine
Interval 19.86 to 59.89
|
52.35 pg/mg creatinine
Interval 35.97 to 76.2
|
54.24 pg/mg creatinine
Interval 38.67 to 76.06
|
|
Concentration of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
After 2 days
|
131.69 pg/mg creatinine
Interval 89.4 to 194.0
|
42.43 pg/mg creatinine
Interval 24.09 to 74.74
|
66.40 pg/mg creatinine
Interval 43.62 to 101.1
|
68.00 pg/mg creatinine
Interval 47.83 to 96.68
|
|
Concentration of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
After 3 days
|
127.57 pg/mg creatinine
Interval 88.64 to 183.6
|
37.74 pg/mg creatinine
Interval 20.39 to 69.85
|
63.40 pg/mg creatinine
Interval 43.18 to 93.1
|
59.96 pg/mg creatinine
Interval 43.31 to 83.02
|
|
Concentration of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
After 5 days
|
127.04 pg/mg creatinine
Interval 88.57 to 182.22
|
32.48 pg/mg creatinine
Interval 17.7 to 59.61
|
53.63 pg/mg creatinine
Interval 36.41 to 78.99
|
55.82 pg/mg creatinine
Interval 40.88 to 76.22
|
|
Concentration of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
Baseline
|
115.30 pg/mg creatinine
Interval 83.91 to 158.43
|
101.92 pg/mg creatinine
Interval 57.26 to 181.43
|
135.02 pg/mg creatinine
Interval 96.24 to 189.43
|
150.11 pg/mg creatinine
Interval 117.61 to 191.6
|
|
Concentration of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
After 1 day
|
104.20 pg/mg creatinine
Interval 74.45 to 145.84
|
51.32 pg/mg creatinine
Interval 28.62 to 92.05
|
82.04 pg/mg creatinine
Interval 56.15 to 119.88
|
77.92 pg/mg creatinine
Interval 58.24 to 104.24
|
PRIMARY outcome
Timeframe: 5 daysCarboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Blood measurements performed in the evening of Day 5. Geometric Least Squares means are provided for biomarkers of exposure (BoExp) in smokers switching from CIG to various THS versions (THS Blade device; THS Induction Mono device; THS Induction Mid device) compared to continuing CIG smoking for 5 days.
Outcome measures
| Measure |
Cigarette
n=19 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the subject's preferred brand of regular (non-mentholated) cigarette between 06:30 AM and 11:00 PM.
(Every subject brought a sufficient number of unopened, single-brand packs of CIG for the entire confinement period.)
CIG: Subject's preferred brand of commercially available regular (non-mentholated) cigarettes. (Cigarettes are not provided by the study sponsor.)
|
THS Blade Device
n=20 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Blade device (using regular THS blade tobacco sticks) between 06:30 AM and 11:00 PM.
THS Blade device: Tobacco Heating System (THS) device with Blade technology for Blade tobacco stick use
|
THS Induction Mono Device
n=21 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mono device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mono device: Tobacco Heating System (THS) device with Induction technology (combined Charger-Holder device for Induction tobacco stick use).
|
THS Induction Mid Device
n=20 Participants
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mid device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mid device: Tobacco Heating System (THS) device with Induction technology (device with Induction stick Holder for Induction tobacco stick use and separate Charger).
|
|---|---|---|---|---|
|
Levels of Carboxyhemoglobin (COHb)
Baseline
|
5.26 % in blood
Interval 4.6 to 6.0
|
4.79 % in blood
Interval 4.0 to 5.8
|
5.17 % in blood
Interval 4.6 to 5.8
|
5.26 % in blood
Interval 4.6 to 6.0
|
|
Levels of Carboxyhemoglobin (COHb)
After 1 day
|
5.10 % in blood
Interval 4.5 to 5.8
|
1.50 % in blood
Interval 1.4 to 1.6
|
1.60 % in blood
Interval 1.3 to 1.9
|
1.60 % in blood
Interval 1.4 to 1.8
|
|
Levels of Carboxyhemoglobin (COHb)
After 2 days
|
5.29 % in blood
Interval 4.4 to 6.4
|
1.51 % in blood
Interval 1.3 to 1.7
|
1.59 % in blood
Interval 1.4 to 1.9
|
1.88 % in blood
Interval 1.5 to 2.4
|
|
Levels of Carboxyhemoglobin (COHb)
After 3 days
|
5.07 % in blood
Interval 4.3 to 5.9
|
1.33 % in blood
Interval 1.2 to 1.5
|
1.77 % in blood
Interval 1.4 to 2.2
|
1.84 % in blood
Interval 1.4 to 2.4
|
|
Levels of Carboxyhemoglobin (COHb)
After 4 days
|
4.77 % in blood
Interval 4.1 to 5.6
|
1.46 % in blood
Interval 1.3 to 1.7
|
1.66 % in blood
Interval 1.3 to 2.1
|
1.56 % in blood
Interval 1.4 to 1.7
|
|
Levels of Carboxyhemoglobin (COHb)
After 5 days
|
4.98 % in blood
Interval 4.1 to 6.0
|
1.38 % in blood
Interval 1.2 to 1.7
|
1.62 % in blood
Interval 1.3 to 2.0
|
1.78 % in blood
Interval 1.4 to 2.2
|
Adverse Events
Cigarette
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
THS Blade Device
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
THS Induction Mono Device
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
THS Induction Mid Device
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Enrolled But Not Randomized
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cigarette
n=19 participants at risk
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the subject's preferred brand of regular (non-mentholated) cigarette between 06:30 AM and 11:00 PM.
(Every subject brought a sufficient number of unopened, single-brand packs of CIG for the entire confinement period.)
CIG: Subject's preferred brand of commercially available regular (non-mentholated) cigarettes. (Cigarettes are not provided by the study sponsor.)
|
THS Blade Device
n=20 participants at risk
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Blade device (using regular THS blade tobacco sticks) between 06:30 AM and 11:00 PM.
THS Blade device: Tobacco Heating System (THS) device with Blade technology for Blade tobacco stick use
|
THS Induction Mono Device
n=21 participants at risk
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mono device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mono device: Tobacco Heating System (THS) device with Induction technology (combined Charger-Holder device for Induction tobacco stick use).
|
THS Induction Mid Device
n=20 participants at risk
Subjects randomized to this arm participated in 5 days of ad libitum use, in confinement, of the THS Induction Mid device (using regular THS induction tobacco sticks) between 06:30 AM and 11:00 PM.
THS Induction Mid device: Tobacco Heating System (THS) device with Induction technology (device with Induction stick Holder for Induction tobacco stick use and separate Charger).
|
Enrolled But Not Randomized
n=11 participants at risk
Subjects who were enrolled, but were not randomized to a study arm.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/19 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/11 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
|
Gastrointestinal disorders
Lip Dry
|
0.00%
0/19 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/20 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/21 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/11 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/21 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/20 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/11 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/19 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/20 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/21 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/11 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/21 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/11 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/19 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/21 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/11 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/19 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/21 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/20 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/11 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/21 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/20 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/11 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/20 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
0.00%
0/11 • Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 39 days.
|
Additional Information
Christelle Haziza, Global Head Clinical Research and Operations
Philip Morris Products S.A.
Phone: +41582421111
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