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

    Related Publications

    Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers

    Clinical Studies

    Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes

    Clinical Studies

    Effect of Switching From Cigarette Smoking to THS on Disease Progression in Mild to Moderate COPD Subjects With Chronic Bronchitis Symptoms

    Clinical Studies

    Reduced HPHC Exposure in Cigarette Smokers Switching to P4M3 Gen. 2.0 Compared to Continuing Smoking, or Smoking Abstinence

    Clinical Studies

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

    Clinical Studies

    Effect of Switching From Cigarette Smoking to THS on Systemic Endothelial Function in Subjects With Established Atherosclerotic Disease

    Clinical Studies

    PMIScience.com is operated by Philip Morris International for the purpose of publishing and disseminating scientific information about Philip Morris International’s efforts in support of its smoke-free product portfolio. This site is a global site for use by scientists, the public health and regulatory communities, and other stakeholders with an interest in tobacco policy. The purpose of this site is not advertising or marketing, nor is it directed at any specific market. It is not intended for use by consumers. New tobacco products sold in the United States are subject to FDA regulation; therefore the content of this site is not intended to make, and nor should it be construed as making, any product related claims in the United States without proper FDA authorization. ​
    ​
    Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.