NCT05385055

Reduction of Exposure, Inflammation, and Oxidative Stress Following At Least 2 Years of Switching to THS Use Compared to Cigarette Smoking

A Cross-sectional, Multi-regional Study to Demonstrate Reduction in Exposure to Key Toxicants, Oxidative Stress, and Inflammation Following At Least 2 Years of Tobacco Heating System (THS) Use Compared to Cigarette Smoking

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 952 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

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, to demonstrate beneficial effects of switching from cigarettes to THS.

Detailed description

The purpose of this study is primarily to demonstrate beneficial effects of switching from cigarette smoking to THS use for at least 2 years compared to cigarette smoking in a real-life condition on both inflammation and oxidative stress status as a proxy for further long-term harm in healthy subjects, using the well-established and fit-to-purpose measures of WBC and 8-epi-PGF2α, respectively, as indicators of the status of these pathways. The study aims also at demonstrating additional benefits on other mechanistic pathways along with inflammation and oxidative stress by the means of additional biomarkers of potential harm (BoPH) and to assess association with functional benefits that are expected to be responsive to the extent of exposure to harmful and potentially harmful constituents (HPHCs).

Conditions

• Inflammation
• Oxidative Stress
• Smoking
• Smoking Abstinence

Interventions

Type	Name	Description
OTHER	THS use	N/A: No intervention was assigned.
OTHER	Cigarette smoking	N/A: No intervention was assigned.
OTHER	Smoking abstinence	N/A: No intervention was assigned.

Timeline

• Start date: 2022-06-13
• Primary completion: 2023-12-27
• Completion: 2024-04-23
• First posted: 2022-05-23
• Last updated: 2024-09-04

Locations

37 sites across 6 countries: Bulgaria, Czechia, Germany, Greece, Japan, Poland