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: Recruiting

      Study Results: No Results Available

      Enrollment: 80 (estimated)

      Study Type: Interventional

      Other IDs: P1-REXC-10

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