Clinical Studies

Reduced Exposure to HPHC in Smokers Switching From Cigarettes to Different Versions of THS

First posted
Oct 31, 2022
Identifier
NCT05599451
Publication Site URL
Topic
Official Title

A Randomized, Controlled, Open-label, 4 Parallel Arms Study to Demonstrate Reductions in Exposure to Selected Harmful and Potentially Harmful Constituents (HPHC) of Cigarette (CIG) Smoke in Healthy Smokers Switching to Different Versions of Tobacco Heating System (THS) Compared to Continuing CIG Smoking, for 5 Days in Confinement

Brief Summary

This is a randomized, controlled, open-label, 4 parallel arm study with a stratified randomization by sex (a quota for each sex [females and males] of at least 40% overall). This study aims to demonstrate the reduction of Biomarkers of Exposure (BoExp) to selected Harmful and Potentially Harmful Constituents (HPHC) in smokers switching from cigarettes (CIG) to each of the Tobacco Heating System (THS) variants with different heating technology (Blade device, Induction Mono device, or Induction Mid device, respectively), compared with smokers who continue to smoke CIG. A reduction of exposure to HPHC is expected in CIG smokers when switching completely to THS.

Summary

Recruitment: Completed

Study Results: Results Available

Enrollment (actual): 91

Study Type: Interventional

Other IDs: P1-REXC-10

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