Trial Outcomes & Findings for Reduction of Exposure, Inflammation, and Oxidative Stress Following at Least 2 Years of Switching to THS Use Compared to Cigarette Smoking (NCT NCT05385055)
NCT ID: NCT05385055
Last Updated: 2026-05-08
Results Overview
Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as percentage of the total hemoglobin saturated with carbon monoxide.
COMPLETED
974 participants
Measured when subject visits study site on day 1.
2026-05-08
Participant Flow
A total of 300 triplets were planned for enrollment (a triplet was defined as one Current Smoker, one THS User, and one Former Smoker - enrolled and matched). A maximum of 330 subjects per group was planned for enrollment - a 10% buffer was intended to ease triplet completion and manage mismatched subjects.
Participant milestones
| Measure |
Cigarette
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
THS User
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smoker
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Overall Study
STARTED
|
322
|
329
|
323
|
|
Overall Study
COMPLETED
|
322
|
329
|
323
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reduction of Exposure, Inflammation, and Oxidative Stress Following at Least 2 Years of Switching to THS Use Compared to Cigarette Smoking
Baseline characteristics by cohort
| Measure |
Cigarette Smokers
n=296 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
THS Users
n=296 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=296 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Total
n=888 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 8.17 • n=41 Participants
|
43.1 years
STANDARD_DEVIATION 7.65 • n=40 Participants
|
43.5 years
STANDARD_DEVIATION 7.91 • n=81 Participants
|
43.3 years
STANDARD_DEVIATION 7.90 • n=140 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=41 Participants
|
119 Participants
n=40 Participants
|
119 Participants
n=81 Participants
|
357 Participants
n=140 Participants
|
|
Sex: Female, Male
Male
|
177 Participants
n=41 Participants
|
177 Participants
n=40 Participants
|
177 Participants
n=81 Participants
|
531 Participants
n=140 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese
|
139 Participants
n=41 Participants
|
139 Participants
n=40 Participants
|
138 Participants
n=81 Participants
|
416 Participants
n=140 Participants
|
|
Race/Ethnicity, Customized
Asian - Non-Japanese
|
0 Participants
n=41 Participants
|
4 Participants
n=40 Participants
|
3 Participants
n=81 Participants
|
7 Participants
n=140 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=81 Participants
|
2 Participants
n=140 Participants
|
|
Race/Ethnicity, Customized
White
|
156 Participants
n=41 Participants
|
150 Participants
n=40 Participants
|
153 Participants
n=81 Participants
|
459 Participants
n=140 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=41 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=81 Participants
|
4 Participants
n=140 Participants
|
|
BMI
|
24.3 kg/m²
STANDARD_DEVIATION 3.07 • n=41 Participants
|
24.5 kg/m²
STANDARD_DEVIATION 3.09 • n=40 Participants
|
24.2 kg/m²
STANDARD_DEVIATION 2.92 • n=81 Participants
|
24.3 kg/m²
STANDARD_DEVIATION 3.03 • n=140 Participants
|
|
Average Daily Product Consumption
10 to 19 cig/day or 10 to 19 heatsticks/day
|
203 Participants
n=41 Participants
|
204 Participants
n=40 Participants
|
203 Participants
n=81 Participants
|
610 Participants
n=140 Participants
|
|
Average Daily Product Consumption
>19 cig/day or >19 heatsticks/day
|
93 Participants
n=41 Participants
|
92 Participants
n=40 Participants
|
93 Participants
n=81 Participants
|
278 Participants
n=140 Participants
|
PRIMARY outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as percentage of the total hemoglobin saturated with carbon monoxide.
Outcome measures
| Measure |
THS Users
n=295 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=294 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=295 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Carboxyhemoglobin (COHb) in Blood
|
1.52 % of CO saturated hemoglobin
Interval 1.44 to 1.6
|
1.49 % of CO saturated hemoglobin
Interval 1.41 to 1.57
|
3.07 % of CO saturated hemoglobin
Interval 2.92 to 3.23
|
PRIMARY outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Concentrations of total NNAL measured in urine and expressed as concentration adjusted for creatinine (pg/mg creatinine).
Outcome measures
| Measure |
THS Users
n=296 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=296 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=294 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) in Urine
|
20.374 pg NNAL/mg creatinine
Interval 16.784 to 24.732
|
4.456 pg NNAL/mg creatinine
Interval 3.68 to 5.396
|
107.671 pg NNAL/mg creatinine
Interval 89.004 to 130.253
|
PRIMARY outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Total count in blood (10\^9 cells/ L). Mean values are provided.
Outcome measures
| Measure |
THS Users
n=285 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=287 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=283 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
White Blood Cell Total Count (WBC) in Blood
|
6.358 10^9 cells/ L
Interval 6.101 to 6.616
|
5.893 10^9 cells/ L
Interval 5.639 to 6.147
|
7.053 10^9 cells/ L
Interval 6.8 to 7.305
|
PRIMARY outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Concentrations of 8-epi-PGF2α measured in urine and expressed as concentration adjusted for creatinine (pg/mg creatinine).
Outcome measures
| Measure |
THS Users
n=296 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=296 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=294 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
8-epi-Prostaglandin-F2α (8-epi-PGF2α) in Urine
|
171.469 pg/mg creatinine
Interval 158.571 to 185.416
|
154.260 pg/mg creatinine
Interval 142.718 to 166.735
|
224.428 pg/mg creatinine
Interval 207.702 to 242.5
|
SECONDARY outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Concentrations of HDL-C (mmol/L) measured in serum.
Outcome measures
| Measure |
THS Users
n=295 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=295 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=294 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
High-Density Lipoprotein Cholesterol (HDL-C)
|
1.590 mmol/L
Interval 1.539 to 1.64
|
1.624 mmol/L
Interval 1.573 to 1.674
|
1.496 mmol/L
Interval 1.446 to 1.545
|
SECONDARY outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Concentrations of sICAM-1 (ng/mL) measured in plasma.
Outcome measures
| Measure |
THS Users
n=296 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=296 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=295 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Soluble Intercellular Adhesion Molecule-1 (sICAM-1)
|
70.8 ng/mL
Interval 67.7 to 74.1
|
69.9 ng/mL
Interval 66.8 to 73.2
|
80.4 ng/mL
Interval 76.8 to 84.1
|
SECONDARY outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Concentrations of 11-DTX-B2 measured in urine and expressed as concentration adjusted for creatinine (pg/mg creatinine).
Outcome measures
| Measure |
THS Users
n=295 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=295 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=293 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
11-dehydrothromboxane B2 (11-DTX-B2)
|
637.98 pg/mg creatinine
Interval 582.11 to 699.21
|
699.35 pg/mg creatinine
Interval 638.64 to 765.83
|
917.04 pg/mg creatinine
Interval 837.79 to 1003.78
|
SECONDARY outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Lower AIx values indicate healthier, more flexible arteries and better cardiovascular outcomes, while higher AIx values reflect greater arterial stiffness and worse outcomes. AIx assessments were conducted using a SphygmoCor XCEL device or similar according to the manufacturer's instructions.
Outcome measures
| Measure |
THS Users
n=286 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=281 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=276 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Augmentation Index (AIx)
|
122.33 percentage of the pulse pressure
Interval 120.64 to 124.02
|
122.30 percentage of the pulse pressure
Interval 120.62 to 123.97
|
125.19 percentage of the pulse pressure
Interval 123.51 to 126.87
|
SECONDARY outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred).
Outcome measures
| Measure |
THS Users
n=296 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=296 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=296 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) %Predicted, Post-bronchodilator (Post-BD)
|
102.090 percentage
Interval 100.499 to 103.68
|
101.034 percentage
Interval 99.447 to 102.622
|
99.107 percentage
Interval 97.528 to 100.685
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Calculated by dividing the number of neutrophils by number of lymphocytes from serum.
Outcome measures
| Measure |
THS Users
n=285 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=286 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=283 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Neutrophil to Lymphocyte Ratio (NLR)
|
1.8339 ratio
Interval 1.7311 to 1.9427
|
1.7822 ratio
Interval 1.6831 to 1.8871
|
1.8218 ratio
Interval 1.7208 to 1.9287
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Concentrations of hs-CRP (nmol/L) measured in serum.
Outcome measures
| Measure |
THS Users
n=295 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=295 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=295 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
High-sensitivity C-Reactive Protein (Hs-CRP)
|
6.30 nmol/L
Interval 5.46 to 7.27
|
6.98 nmol/L
Interval 6.05 to 8.04
|
7.01 nmol/L
Interval 6.09 to 8.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Concentrations of HCY (μmol/L) measured in plasma.
Outcome measures
| Measure |
THS Users
n=295 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=296 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=295 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Homocysteine (HCY)
|
9.79 umol/L
Interval 9.35 to 10.26
|
9.42 umol/L
Interval 8.99 to 9.86
|
10.60 umol/L
Interval 10.13 to 11.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Concentrations of MPO (ng/mL) measured in plasma.
Outcome measures
| Measure |
THS Users
n=296 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=296 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=295 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Myeloperoxidase (MPO)
|
174.5 ng/mL
Interval 154.6 to 196.9
|
174.6 ng/mL
Interval 154.9 to 196.7
|
183.8 ng/mL
Interval 163.3 to 206.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Concentrations of TG (mmol/L) measured in blood.
Outcome measures
| Measure |
THS Users
n=295 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=295 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=294 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Triglycerides (TG)
|
1.203 mmol/L
Interval 1.121 to 1.29
|
1.147 mmol/L
Interval 1.069 to 1.229
|
1.217 mmol/L
Interval 1.135 to 1.304
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Concentrations of Fibrinogen (g/L) measured in plasma.
Outcome measures
| Measure |
THS Users
n=294 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=292 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=293 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Fibrinogen
|
2.858 g/L
Interval 2.78 to 2.939
|
2.753 g/L
Interval 2.678 to 2.829
|
2.865 g/L
Interval 2.789 to 2.944
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
HbA1c measured in whole blood (%).
Outcome measures
| Measure |
THS Users
n=295 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=295 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=294 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Glycated Hemoglobin (HbA1c)
|
5.42 % (of red blood cells)
Interval 5.37 to 5.46
|
5.43 % (of red blood cells)
Interval 5.38 to 5.47
|
5.50 % (of red blood cells)
Interval 5.46 to 5.55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Measured pre-bronchodilator
Outcome measures
| Measure |
THS Users
n=296 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=296 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=296 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second/Forced Vital Capacity (FEV1/FVC) Ratio Pre-bronchodilator
|
0.784 ratio
Interval 0.777 to 0.792
|
0.787 ratio
Interval 0.779 to 0.795
|
0.776 ratio
Interval 0.768 to 0.783
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Measured post bronchodilator
Outcome measures
| Measure |
THS Users
n=296 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=296 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=296 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second/Forced Vital Capacity (FEV1/FVC) Ratio Post Bronchodilator
|
0.810 ratio
Interval 0.803 to 0.818
|
0.813 ratio
Interval 0.806 to 0.82
|
0.799 ratio
Interval 0.792 to 0.806
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Measured pre-bronchodilator (% predicted values).
Outcome measures
| Measure |
THS Users
n=296 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=296 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=296 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second/Forced Vital Capacity (% Predicted) Pre-bronchodilator
|
96.145 % predicted
Interval 95.166 to 97.125
|
96.355 % predicted
Interval 95.386 to 97.324
|
94.974 % predicted
Interval 94.013 to 95.934
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
Measured post-bronchodilator (% predicted values).
Outcome measures
| Measure |
THS Users
n=296 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=296 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=296 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second/Forced Vital Capacity (% Predicted) Post-bronchodilator
|
99.307 % predicted
Interval 98.386 to 100.228
|
99.477 % predicted
Interval 98.564 to 100.39
|
97.823 % predicted
Interval 96.918 to 98.728
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
NEQ measured in urine and expressed as concentration adjusted for creatinine.
Outcome measures
| Measure |
THS Users
n=296 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=294 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=289 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
Nicotine Equivalents (NEQ) in Urine (Expressed as Concentration Adjusted to Creatinine)
|
8.1844 mg/g creatinine
Interval 6.8521 to 9.7758
|
0.3104 mg/g creatinine
Interval 0.2604 to 0.3699
|
8.6351 mg/g creatinine
Interval 7.2487 to 10.2868
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured when subject visits study site on day 1.Population: The analysis population (Modified Per-Protocol Analysis Set \[mPP\]) consisted of all randomized subjects, with at least one product use experience and at least one valid non-safety assessment, and excluded subjects with major deviations impacting the evaluability of the objectives. Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
2CyEMA measured in urine and expressed as concentration adjusted to creatinine.
Outcome measures
| Measure |
THS Users
n=296 Participants
THS users with a minimum of 2 years of THS use
THS use: N/A: No intervention was assigned.
|
Former Smokers
n=296 Participants
Former cigarette smokers with minimum of 2 years of smoking abstinence
Smoking abstinence: N/A: No intervention was assigned.
|
Cigarette Smokers
n=294 Participants
Current cigarette smokers
Cigarette smoking: N/A: No intervention was assigned.
|
|---|---|---|---|
|
2-Cyanoethyl Mercapturic Acid N-Acetyl-S-(2-cyanoethyl)-L-cysteine (2CyEMA)
|
3.2101 ng/mg creatinine
Interval 2.7433 to 3.7563
|
1.3565 ng/mg creatinine
Interval 1.1608 to 1.5852
|
78.8857 ng/mg creatinine
Interval 67.5577 to 92.1132
|
Adverse Events
Cigarette
THS User
Former Smoker
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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