CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 974 enrolled
Drug / intervention
THS use +2 moreother
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Age 30–60 years old
  • ✓Healthy based on ECG, spirometry, vital signs, physical exam, and investigator assessment
  • ✓Cigarette smokers: ≥10 cigarettes/day average over past 2 years and ≥10 years total
  • ✓THS users: ≥10 HeatSticks/day over past 2 years, prior ≥8 years cigarette smoking, <30 cigarettes/month and <daily other tobacco/e-cigarettes in past 2 years
Key exclusion· 16
  • ✕Clinically relevant diseases (gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, urological, immunological, pulmonary, cardiovascular) or conditions affecting subject safety or study validity
  • ✕Abnormal findings on ECG, vital signs, spirometry, physical exam, or medical history deemed clinically significant
  • ✕Acute illness or fever (>37.5°C) within 30 days prior to screening, or confirmed/suspected active COVID-19
  • ✕Systemic medication affecting WBC or 8-epi-PGF2α within 5 half-lives prior to enrollment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05385055
NCT05385055N/ACompleted
CompareCT.gov

A Cross-sectional, Multi-regional Study to Demonstrate Reduction in Exposure to Key Toxicants, Oxidative Stress, and Inflammation Following at Least 2 Years of Tobacco Heating System (THS) Use Compared to Cigarette Smoking

Philip Morris Products S.A.·observational·Posted May 23, 2022·Updated May 8, 2026

In Brief

An observational study evaluating THS use, Cigarette smoking, and 1 other intervention for Inflammation and 3 related conditions. Completed, enrolled 974 participants across 37 sites in 6 countries.

Detailed Summary

This is a cross-sectional 3-group study with subjects enrolled and matched by region (Asia, Europe), age, sex, and average daily product consumption over the last 2 years as self-reported. The study will be conducted as a multi-center and multi-regional study.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInflammation, Oxidative Stress, Smoking, Smoking Abstinence
CountriesBulgaria, Czechia, Germany, Greece, Japan, Poland
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 23, 2022
Enrollment StartJun 13, 2022
Primary CompletionDec 27, 2023
Study CompletionApr 23, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.1 years ago

Interventions

THS useother

N/A: No intervention was assigned.

Cigarette smokingother

N/A: No intervention was assigned.

Smoking abstinenceother

N/A: No intervention was assigned.