N/A
N=974
Reduction of Exposure, Inflammation, and Oxidative Stress Following at Least 2 Years of Switching to THS Use Compared to Cigarette Smoking
Inflammation · Oxidative Stress · Smoking · Smoking Abstinence
Bottom Line
View on ClinicalTrials.gov: NCT05385055 ↗Enrolled (actual)
974
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Carboxyhemoglobin (COHb) in Blood — 3.07; 1.52; 1.49 % of CO saturated hemoglobin — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- THS use (Other); Cigarette smoking (Other); Smoking abstinence (Other)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Carboxyhemoglobin (COHb) in Blood |
3.07; 1.52; 1.49 | <0.001 sig |
| PRIMARY Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) in Urine |
107.671; 20.374; 4.456 | <0.001 sig |
| PRIMARY White Blood Cell Total Count (WBC) in Blood |
7.053; 6.358; 5.893 | <0.001 sig |
| PRIMARY 8-epi-Prostaglandin-F2α (8-epi-PGF2α) in Urine |
224.428; 171.469; 154.260 | <0.001 sig |
| SECONDARY High-Density Lipoprotein Cholesterol (HDL-C) |
1.496; 1.590; 1.624 | 0.002 sig |
| SECONDARY Soluble Intercellular Adhesion Molecule-1 (sICAM-1) |
80.4; 70.8; 69.9 | <0.001 sig |
| SECONDARY 11-dehydrothromboxane B2 (11-DTX-B2) |
917.04; 637.98; 699.35 | <0.001 sig |
| SECONDARY Augmentation Index (AIx) |
125.19; 122.33; 122.30 | <0.001 sig |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) %Predicted, Post-bronchodilator (Post-BD) |
99.107; 102.090; 101.034 | 0.002 sig |
Summary
This is a cross-sectional 3-group study with subjects enrolled and matched by region (Asia, Europe), age, sex, and average daily product consumption over the last 2 years as self-reported. The study will be conducted as a multi-center and multi-regional study.
Eligibility Criteria
Inclusion Criteria
- Subject is able to understand the information provided in the main ICF and has signed the main ICF.
- Subject is 30-60 years old.
- Subject is healthy based on ECG, spirometry, vital signs, physical examination, medical history and Investigator's assessment.
Cigarette smokers:
- Has smoked ≥ 10 cigarettes/day on average (no brand restriction) over the past 2 years prior to screening.
- Has smoked ≥ 10 cigarettes/day on average (no brand restriction) for at least 10 years.
- Has not used other tobacco and nicotine products apart from cigarettes on a daily basis over the past 2 years prior to screening.
- Smoking status will be verified by urinary cotinine test (≥ 200 ng/mL) and CO breath test (≥ 10 ppm (1)).
THS users:
- Has used ≥ 10 HeatSticks/day on average over the past 2 years prior to screening.
- Has smoked ≥ 10 cigarettes/day on average (no brand restriction) for at least 8 years prior to switching to THS.
- Has smoked 37.5°C or an acute illness (e.g., upper-respiratory-tract infection, viral infection, etc.…) or the subject is confirmed or suspected active COVID-19 infection (based on the signs and symptoms observed at the time of assessment) at screening.
- The subject has used any prescribed or over-the-counter systemic medication with an impact on WBC or 8-epi-PGF2α within 5 half-lives of the medication prior to enrollment in the study (please refer to Appendix B).
- Subject has high blood pressure (hypertension), defined as > 139 mmHg systolic and/or > 89 mmHg diastolic or is currently treated with medication controlling high blood pressure.
- The subject has (FEV1/FVC) 12% and > 200 mL from pre- to post-BD values).
- The subject has a history of allergic reactions to salbutamol.
- The subject has a body mass index (BMI) < 18.5 or ≥ 30 kg/m2.
- The subject has positive alcohol and/or drug screening test results.
- The subject has donated or received whole blood or blood products within 3 months prior to V1.
- The subject has been previously screened for this study.
- The subject is a current or former employee of the tobacco or e-cigarettes industry or of their first-degree relatives (parent, sibling, and child).
- The subject is an employee of the investigational site or any other parties involved in the study or of their first-degree relatives (parent, sibling, and child).
- The subject has participated in a clinical study within 3 months prior to V1.
- For women only: the subject is pregnant (does have a positive pregnancy test) or breast-feeding.
Data sourced from ClinicalTrials.gov (NCT05385055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.