At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating THS Blade device, THS Induction Mono device, and 2 other interventions for Smoking and 2 related conditions. Completed, enrolled 91 participants across 1 site.
Detailed Summary
This was 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 aimed 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 continued to smoke CIG.
Study Details
Timeline
Interventions
Tobacco Heating System (THS) device with Blade technology for Blade tobacco stick use
Tobacco Heating System (THS) device with Induction technology (combined Charger-Holder device for Induction tobacco stick use).
Tobacco Heating System (THS) device with Induction technology (device with Induction stick Holder for Induction tobacco stick use and separate Charger).
Subject's preferred brand of commercially available regular (non-mentholated) cigarettes. (Cigarettes are not provided by the study sponsor.)