Smoking Clinical Trial - Reduced Exposure to HPHC in Smokers Switching

Status Completed

Clinical Trial 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.

Clinical Trial Description

The exposure period in confinement will provide information on exposure reductions achievable in a well-controlled environment with full control on daily THS stick consumption and compared to CIG smoking. The primary hypothesis tested in this study is that BoExp considered for the primary objective will be reduced for each THS variant (Blade device, or Induction Mono device, or Induction Mid device, respectively) in subjects who adhere to switching to THS for 5 days, compared to subjects continuing CIG smoking. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05599451
Study type	Interventional
Source	Philip Morris Products S.A.
Contact
Status	Completed
Phase	N/A
Start date	November 16, 2022
Completion date	May 15, 2023

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms