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NCT05385055
Reduction of Exposure, Inflammation, and Oxidative Stress Following At Least 2 Years of Switching to THS Use Compared to Cigarette Smoking
trial testing THS use in Inflammation in 952 participants. Completed in 23 April 2024.
27 December 2023
Quick facts
| Lead sponsor | Philip Morris Products S.A. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 952 |
| Start date | 13 June 2022 |
| Primary completion | 27 December 2023 |
| Estimated completion | 23 April 2024 |
| Sites | 37 locations across Japan, Greece, Germany, Poland, Bulgaria, Czechia |
Drugs / interventions tested
- THS use
- Cigarette smoking
- Smoking abstinence
Conditions studied
- Inflammation — all drugs for Inflammation →
- Oxidative Stress — all drugs for Oxidative Stress →
- Smoking — all drugs for Smoking →
- Smoking Abstinence — all drugs for Smoking Abstinence →
Sponsor
Philip Morris Products S.A. — full company profile →
Who can join
Adults 30 to 60, any sex, with Inflammation or Oxidative Stress. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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, to demonstrate beneficial effects of switching from cigarettes to THS.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Differences in biomarkers of potential harm after 2+ years of tobacco heating system use compared to cigarette smoking: a cross-sectional study.
Ansari SM, Leroy P, de La Bourdonnaye G, Pouly S, et al · · 2025 · cited 5× · PMID 39882959 · DOI 10.1080/1354750x.2025.2461069
Verify or expand the search:
- PubMed search for NCT05385055
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of THS use
Trials testing the same drug.
- NCT05569005 — Effect of Switching From Cigarette Smoking to THS on Disease Progression in Mild to Moderate COPD Subjects With Chronic · NA · terminated
Other recruiting trials for Inflammation
Currently open trials in the same condition.
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- NCT07171450 — Cognitive Remediation · NA · recruiting
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Other Philip Morris Products S.A. trials
Trials by the same sponsor.
- NCT07443631 — Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants · NA · recruiting
- NCT07459712 — Pharmacokinetics and Pharmacodynamics of THS With LEVIA Compared to THS With TEREA and to Cigarettes · NA · active not recruiting
- NCT07408180 — Exploratory Randomized, Controlled, Dose-response Study on the Impact of Nicotine From Five Variants of a Nicotine Table · NA · active not recruiting
- NCT07135648 — Nicotine Pharmacokinetics and Pharmacodynamics of Two Variants of VM 1.0 Compared to Cigarettes in Adult Current Smokers · NA · active not recruiting
- NCT06171490 — Pharmacokinetics and Comparative Bioavailability of Nicotine From Two Variants of NP2, NP2-4mg and NP2-6mg, Compared to · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05385055 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Philip Morris Products S.A.
- Last refreshed: 4 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05385055.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing