MedTrace Logo

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

NCT05599451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2024-09-20

Study results available
· View outcomes & findings →

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.

Conditions

  • Smoking
  • Tobacco Smoking
  • Tobacco Use

Interventions

OTHER

THS Blade device

Tobacco Heating System (THS) device with Blade technology for Blade tobacco stick use

OTHER

THS Induction Mono device

Tobacco Heating System (THS) device with Induction technology (combined Charger-Holder device for Induction tobacco stick use).

OTHER

THS Induction Mid device

Tobacco Heating System (THS) device with Induction technology (device with Induction stick Holder for Induction tobacco stick use and separate Charger).

OTHER

CIG

Subject's preferred brand of commercially available regular (non-mentholated) cigarettes. (Cigarettes are not provided by the study sponsor.)

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • Devinda Weeraratne, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-04
Primary Completion
2023-02-04
Completion
2023-05-15

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05599451 on ClinicalTrials.gov