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Heated tobacco vs cigarettes: which is less harmful?

NCT ID NCT05385055

Knowledge-focused Sponsor: Philip Morris Products S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether people who used a tobacco heating system for at least 2 years had lower levels of harmful chemicals, cell stress, and inflammation in their bodies compared to cigarette smokers. About 974 healthy adults aged 30-60 from Asia and Europe took part. The goal was to measure differences in blood and urine markers, not to treat or cure any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

974 people

The number who actually took part.

Started

Jun 2022

Finished

Apr 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population was recruited through social media and traditional display advertising. The subjects included current cigarette smokers, current THS users (with a minimum of 2 years THS use), and former cigarette smokers (with a minimum of 2 years of smoking abstinence).

Ages

30 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject is able to understand the information provided in the main ICF and has signed the main ICF. * Subject is 30-60 years old. * Subject is healthy based on ECG, spirometry, vital signs, physical examination, medical history and Investigator's assessment. Cigarette smokers: * Has smoked ≥ 10 cigarettes/day on average (no brand restriction) over the past 2 years prior to screening. * Has smoked ≥ 10 cigarettes/day on average (no brand restriction) for at least 10 years. * Has not used other tobacco and nicotine products apart from cigarettes on a daily basis over the past 2 years prior to screening. * Smoking status will be verified by urinary cotinine test (≥ 200 ng/mL) and CO breath test (≥ 10 ppm (1)). THS users: * Has used ≥ 10 HeatSticks/day on average over the past 2 years prior to screening. * Has smoked ≥ 10 cigarettes/day on average (no brand restriction) for at least 8 years prior to switching to THS. * Has smoked \< 30 cigarettes/month and used other tobacco products or e-cigarettes \< daily over the past 2 years prior to screening. * Product use will be verified by urinary cotinine test (≥ 200 ng/mL) and CO breath test (\< 10 ppm). Former cigarette smokers: * Has not smoked cigarettes or used any tobacco or nicotine-containing products on a daily basis over the past 2 years prior to screening. * Has smoked ≥ 10 cigarettes/day on average (no brand restriction) for at least 8 years prior to stopping smoking. * Smoking status will be verified by urinary cotinine test (\< 100 ng/mL) and CO breath test (\< 10 ppm). Exclusion Criteria: * As per the judgment of the Investigator, the subject cannot participate in the study for any reason (e.g., medical, psychiatric and/or social reason). The Investigator should specifically evaluate the subject's eligibility considering COVID-19 risk factors and local situation. * The subject is legally incompetent or physically/mentally incapable of giving consent (e.g., emergency situation, under guardianship, in a social or sanitary establishment, prisoner or involuntarily incarcerated). * The subject has/had clinically relevant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, urological, immunological, pulmonary, and cardiovascular disease) or conditions that in the opinion of the investigator would jeopardize the safety of the subject or affect the validity of the study results. * The subject has abnormal findings on physical examination, ECG, vital signs, spirometry or in the medical history, deemed clinically significant by investigators. * The subject has/had within 30 days prior to screening a body temperature \>37.5°C or an acute illness (e.g., upper-respiratory-tract infection, viral infection, etc.…) or the subject is confirmed or suspected active COVID-19 infection (based on the signs and symptoms observed at the time of assessment) at screening. * The subject has used any prescribed or over-the-counter systemic medication with an impact on WBC or 8-epi-PGF2α within 5 half-lives of the medication prior to enrollment in the study (please refer to Appendix B). * Subject has high blood pressure (hypertension), defined as \> 139 mmHg systolic and/or \> 89 mmHg diastolic or is currently treated with medication controlling high blood pressure. * The subject has (FEV1/FVC) \< 0.7 and FEV1 \< 80% predicted value at post-bronchodilator (BD) spirometry. * The subject has (FEV1/FVC) \< 0.75 (pre-BD) and reversibility in FEV1 (that is both \> 12% and \> 200 mL from pre- to post-BD values). * The subject has a history of allergic reactions to salbutamol. * The subject has a body mass index (BMI) \< 18.5 or ≥ 30 kg/m2. * The subject has positive alcohol and/or drug screening test results. * The subject has donated or received whole blood or blood products within 3 months prior to V1. * The subject has been previously screened for this study. * The subject is a current or former employee of the tobacco or e-cigarettes industry or of their first-degree relatives (parent, sibling, and child). * The subject is an employee of the investigational site or any other parties involved in the study or of their first-degree relatives (parent, sibling, and child). * The subject has participated in a clinical study within 3 months prior to V1. * For women only: the subject is pregnant (does have a positive pregnancy test) or breast-feeding.

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Conditions

The condition(s) this trial relates to.

Inflammation inflammatory disease Smoking

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammation Oxidative stress Smoking Smoking abstinence

Contacts and locations

Locations

  • Aristotle University Thessaloniki/Papageorgiou Hospital

    Thessaloniki, 56403, Greece

  • Bioresearch Group

    Nadarzyn, 05-830, Poland

  • Centrum Medyczne Pratia

    Katowice, 40-081, Poland

  • Centrum für Diagnostik und Gesundheit, Klinische Forschung und Entwicklung

    München, Germany

  • Clinical Medical Research Sp. z o.o.

    Katowice, 40-156, Poland

  • Clintrial s.r.o.

    Prague, Czechia

  • Hakata Clinic

    Fukuoka, Japan

  • Klinische Forschung Dresden GmbH

    Sachsen, 1069, Germany

  • Klinische Forschung Hamburg GmbH

    Hamburg, 20253, Germany

  • Klinische Forschung Hannover-Mitte GmbH

    Hanover, 30159, Germany

  • Klinische Forschung Karlsruhe GmbH

    Karlsruhe, 76137, Germany

  • Medical Center ReSpiro

    Razgrad, 7200, Bulgaria

  • Medical Center Zara-Med EOOD

    Stara Zagora, 6000, Bulgaria

  • Medical Centre Asklepii

    Kyustendil, 2600, Bulgaria

  • Medical Centre Leo Clinic EOOD

    Lovech, 5500, Bulgaria

  • National and Kapodistrian University of Athens, Medical school, Attikon Hospital, 2nd Cardiology Department

    Athens, Greece

  • Nishikumamoto Hospital

    Minami, Japan

  • OCROM Clinic

    Osaka, 6560853, Japan

  • OPHAC Hospital

    Osaka, 5320003, Japan

  • Ordinance praktickeho lekai'e

    Přeštice, 33401, Czechia

  • Praglandia s.r.o.

    Prague, 15000, Czechia

  • Praxis Reinfeld Mitte

    Reinfeld, Germany

  • PreventaMed s.r.o.

    Olomouc, 77900, Czechia

  • Private Internal ambulance

    Karlovy Vary, 360 17, Czechia

  • Samoncho Clinic

    Tokyo, 1600017, Japan

  • Schaum/Hecht_RED Institut fur medizinische Forschung und Fortbildung GmbH

    Oldenburg in Holstein, 23758, Germany

  • Sumida Hospital

    Tokyo, Japan

  • Synexus Clinical Research GmbH

    Frankfurt, 60313, Germany

  • Synexus Polska Sp zoo OddziaL w Lodzi

    Lodz, 90-127, Poland

  • ToCROM Clinic

    Tokyo, 160-0008, Japan

  • Tomed Tomasz Miszalski-Jamka

    Krakow, 31-353, Poland

  • Velocity Clinical Research Germany GmbH

    Berlin, 10787, Germany

  • Velocity Clinical Research Leipzig

    Leipzig, 4103, Germany

  • Vestra Clinics s.r.o.

    Rychnov nad Kněžnou, Czechia

  • Yokohama Minoru Clinic

    Kanagawa, 2320064, Japan

  • Zdravi - fit, s.r.o.

    Protivín, 398 11, Czechia

  • emovis GmbH

    Berlin, Germany

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