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COPD patients may breathe easier by switching to heated tobacco

NCT ID NCT07108166

Symptom relief 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Updated 2 times

Summary

This study looks at whether people with COPD and chronic bronchitis who switch from regular cigarettes to a tobacco heating system feel better and breathe easier. About 290 adults aged 40 and older who have smoked for at least 10 years will take part. Researchers will measure cough frequency, lung function, and walking ability to see if the switch leads to real improvements.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 290 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

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.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Adult, both sexes, aged ≥ 40 years. * Patient has read, understood, and signed the written informed consent form (ICF), which has received IEC or IRB approval. * Patient with body mass index (BMI) 17.6-40.0 kg/m2 and body weight \> 50 kg (male) or \> 40 kg (female). Checked at V1 and V2. * Patient has a CIG smoking history ≥ 10 years. * Patient has been smoking ≥ 10 commercially available and/or roll-your-own CIG/day on average (no brand restriction) for at least the last year (based on self-reporting). Smoking status will be verified by Urine cotinine test (UCOT) ≥200 ng/mL. Intermittent CIG smoking abstinence, with or without Smoking Cessation Treatment during these attempts, not exceeding 10 days total within the past year will be allowed. Checked at V1 and V2. * Patient has been advised to quit smoking, informed of smoking risks and of cessation programs as per SoC at V2, and is not willing to quit CIG use for the study duration. Checked at V1 and V2. * Patient agrees to be randomized into one of the two study arms. Checked at V2. * Patient with confirmed COPD via spirometry performed at V1 (FEV1/FVC \<70%, post-bronchodilator (-BD)) and COPD severity classified by the Global Initiative for Chronic Obstructive Lung Diseases (GOLD) as GOLD 2 or 3 (30%≤ FEV1 \< 80% predicted, -BD) with presence of chronic bronchitis (cough and mucus most of the days for \> three months a year for the two consecutive years prior to the screening visit). Checked at V2. * Patient has cough frequency of ≥ 10 cough/hour during daytime from objective count sensor applied at V1, used to verify eligibility at V2. (Daytime is defined as occurring between 07:00:00 and 22:59:59, based on the local time zone of the site where the patient is assessed.) Exclusion Criteria: * Patient who self-report concomitant daily use of inhaled cannabis or any type of nicotine containing products other than CIG within the last year. * Patient with COPD (moderate or severe) exacerbation that has not resolved according to the GOLD standard (e.g., requirement of additional therapy) or investigator's discretion. Checked at V1 and V2. * Patient with currently active cancer or history of any cancer within the last 5 years prior to V1, except for those with basal cell carcinoma of the skin. * Patient with acute worsening symptoms of chronic bronchitis or other active respiratory or systemic infections that have not resolved. Checked at V1 and V2. * Patient with medical condition(s) that would jeopardize his(her) safety in the context of this study (e.g., safety laboratory parameters, abnormal ECG) or with a condition that would jeopardize study results (e.g., gastroesophageal reflux disease (GERD), heart failure, severe chronic lung emphysema, active symptomatic hay fever), as per Investigator's discretion. Checked at V1 and V2. * Patient is legally incompetent, physically, and/or mentally incapable of giving consent (e.g., emergency situation, under guardianship, in a social or sanitary establishment, prisoner or involuntarily incarcerated, unable to read). * Patient with a history of asthma. * Employee of the investigational site or any other party involved in the study, or their first-degree relatives (parent, child, spouse). * Current or former employee of the tobacco or e-cigarette industry or their 1st-degree relatives. * Patient with active or history of alcohol and/or drug abuse within the past year. * Patient with positive serological tests for human immunodeficiency virus (HIV) 1/2, hepatitis B or C (Hep B/C). * Patient with any concomitant issues (e.g., medical, psychiatric, and/or social reason) that, as per Investigator's discretion, would place the study patient at an unacceptable risk for participation in the study. * Patient who participated in any trial (for investigational medicine, or other type of intervention) that may have interfered with COPD disease progression and symptoms (including cough and dyspnea) within the last three months as per investigator's discretion. * Patient using any systemic (injectable or oral) corticosteroids (acute or chronic treatments) or oxygen therapy in the last 2 months excluding short term use for a COPD exacerbation. * Patient currently being treated with angiotensin-converting enzyme (ACE) inhibitors or opioids, or those who have used ACE inhibitors within 4 weeks or opioids within 1 week prior to screening. Checked at V1 and V2. * Patient treated with biologic therapies for COPD (e.g., Dupilumab) in the last 6 months. * Female patient is pregnant, breastfeeding or lactating, or anticipating becoming pregnant withing the duration of the study. Checked at V1 and V2. * Female of childbearing potential who is capable of getting pregnant, defined as a female patient who does not agree to use an acceptable method of effective contraception during the entire study, a female patient that is not surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months or postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year). Checked at V1 and V2.

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Conditions

The condition(s) this trial relates to.

chronic bronchitis chronic obstructive pulmonary disease COPD, severe early onset nicotine dependence Smoking Tobacco Use

As listed by the trial registrant

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

COPD Smoking Tobacco use

Contacts and locations

Locations

  • 4 Medical Clinical Solutions (4MCS)

    London, IG1 4HP, United Kingdom

  • 4 Medical Clinical Solutions (4MCS)

    Manchester, M27 8FF, United Kingdom

  • AI Clinical Research

    Sibiu, 550082, Romania

  • Accurate Clinical Research, Inc.

    Humble, Texas, 77338, United States

  • Advanced Research Institute, Inc

    New Port Richey, Florida, 34653, United States

  • Advanced Research Institute, Inc

    St. Petersburg, Florida, 33710, United States

  • Akashi Medical Center

    Hyōgo, 674-0063, Japan

  • Alergia s. r. o.

    Topoľčany, 955 01, Slovakia

  • Alfa Medical Research

    Davie, Florida, 33024, United States

  • Ames Research Center

    Bragadiru, 077025, Romania

  • Ames Research Center

    Calarasi, 910103, Romania

  • BAG Peter Fried / Dr. med. Roman Rubin

    Wiesbaden, 65183, Germany

  • Ballenberger Freytag Wenisch - Institut für klinische Forschung GmbH

    Neu-Isenburg, 63263, Germany

  • BioResearch Group Sp. z.o.o

    Kajetany, 05-830, Poland

  • Biomed Research & Medical Center.Llc

    Miami, Florida, 33156, United States

  • CCR Ostrava s.r.o.

    Ostrava, 702 00, Czechia

  • CDC Research Institute

    Port Saint Lucie, Florida, 34952, United States

  • Central Florida Pulmonary Group, P.A.

    Orlando, Florida, 32803, United States

  • Centrum Medycyny Oddechowej Mroz Spolka jawna

    Bialystok, 15-044, Poland

  • Clinical Research Hospital Tokyo

    Yotsuya, 160-0004, Japan

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765, United States

  • Clintrial Medical Centre SRL

    Dobrosloveni, 237143, Romania

  • Comprehensive Medical & Research Center

    Plantation, Florida, 33317, United States

  • D&H Doral Research Center

    Doral, Florida, 33122, United States

  • D&H National Research Center- Miami

    Miami, Florida, 33155.0, United States

  • D&H Pompano Research Center

    Margate, Florida, 33063, United States

  • D&H Tamarac Research Center

    Tamarac, Florida, 33321, United States

  • Dobrostan

    Wroclaw, 53-301, Poland

  • EMDA Clincal Research

    Miami, Florida, 33126, United States

  • El Paso Pulmonary Association

    El Paso, Texas, 79902, United States

  • Element Research Group

    San Antonio, Texas, 78258, United States

  • Facharzt für Innere Medizin und Pneumologie

    Leipzig, 04157, Germany

  • Felicidad Med Research

    Hialeah, Florida, 33012, United States

  • Florida International Medical Research

    Coral Gables, Florida, 33134, United States

  • Fukuwa Clinic

    Tokyo, 104-0031, Japan

  • FutureMeds Frankfurt

    Offenbach, 63065, Germany

  • FutureMeds Krakowskie Centrum Medyczne

    Krakow, 31-501, Poland

  • FutureMeds Liverpool

    Metropolitan Borough of Wirral, CH62 6EE, United Kingdom

  • FutureMeds Targówek

    Warsaw, 03-291, Poland

  • FutureMeds Warszawa Centrum

    Warsaw, 00-215, Poland

  • FutureMeds Wrocław

    Wroclaw, 53-673, Poland

  • FutureMeds Łódź

    Lodz, 91-363, Poland

  • Global Health Clinical Trials Corp.

    Miami, Florida, 33165, United States

  • Guardian Angel

    Tampa, Florida, 33614, United States

  • HDH Research Inc

    Houston, Texas, 77022, United States

  • Harmony Clinical Research

    North Miami Beach, Florida, 33162, United States

  • Houston Pulmonary Medicine Associates

    Houston, Texas, 77089, United States

  • Klifeck GmbH

    Delitzsch, 4509, Germany

  • Klinische Forschung Berlin Mitte /Pratia Germany

    Berlin, 10117, Germany

  • Klinische Forschung Hannover-Mitte GmbH /Pratia Germany

    Hanover, 30159, Germany

  • Klinische Forschung Karlsruhe GmbH / Pratio Germany

    Karlsruhe, 76137, Germany

  • Kouwa Clinic

    Tokyo, 170-0003, Japan

  • LinQ Research, LLC

    Pearland, Texas, 77584, United States

  • Lungenpraxis Witten

    Witten, 58452, Germany

  • MHAT Lyulin EAD

    Sofia, 1336, Bulgaria

  • MHAT Rahila Angelova

    Pernik, 2300, Bulgaria

  • MUDr. Otakar Hokynar - plicni ambulance

    Kralupy nad Vltavou, 278 01, Czechia

  • Maebashi North Hospital

    Gunma, 371-0054, Japan

  • Med-Care Research Corp

    Miami, Florida, 33125, United States

  • MedQuest Translational Sciences LLC

    Miami Lakes, Florida, 33016.0, United States

  • Medical Center Hera EOOD

    Sofia, 1510, Bulgaria

  • Medical Center Pulmovision Ltd

    Sofia, 1756, Bulgaria

  • Medicon a.s.

    Prague, 140 00, Czechia

  • Medrasa Clinical Research

    Sherman, Texas, 75092, United States

  • Melgar-Caro Medcenter and Community Research

    Miami, Florida, 33145, United States

  • Metroplex Pulmonary & Sleep Center

    McKinney, Texas, 75069, United States

  • Metropolitan Clinical Research Center

    Tamarac, Florida, 33321, United States

  • New Life Medical Research Center, Inc

    Hialeah, Florida, 33012, United States

  • Newgen Health Group

    Miami, Florida, 33176, United States

  • Omega Research Debary, LLC

    DeBary, Florida, 32713, United States

  • Optimum Clinical Trial Group

    Tampa, Florida, 33612, United States

  • Ordinace pro tbc a respirační nemoci s.r.o.

    Olomouc, 779 00, Czechia

  • PANACEUM s.r.o.

    Košice, 040 01, Slovakia

  • POIS Sachsen GmbH

    Leipzig, 4509, Germany

  • Panthera Biopartners

    Enfield, EN3 4GS, United Kingdom

  • Panthera Biopartners

    Glasgow, G51 4TF, United Kingdom

  • Panthera Biopartners

    Preston, PR2 9QB, United Kingdom

  • Panthera Biopartners

    Rochdale, OL11 4AU, United Kingdom

  • Panthera Biopartners

    Sheffield, S2 5FX, United Kingdom

  • Panthera Biopartners

    York, YO24 4LJ, United Kingdom

  • Pharma Medical Innovations

    Miami Lakes, Florida, 33014, United States

  • Pioneer Research Solutions Inc

    Houston, Texas, 77099, United States

  • Pivotal Research Solutions

    Stonecrest, Georgia, 30038, United States

  • Plucna ambulancia Hrebenar S.R.O.

    Spišská Nová Ves, 5201, Slovakia

  • Pneumologie Varnsdorf s.r.o.

    Varnsdorf, 407 47, Czechia

  • Praxis Reinfeld Mitte

    Reinfeld, 23858, Germany

  • Premier Pulmonary Critical Care and Sleep Medicine

    Denison, Texas, 75020, United States

  • Professional Research Center Inc

    Miami, Florida, 33172, United States

  • Prolato Research LLC.

    Houston, Texas, 77054, United States

  • Prvni plicni ambulance s.r.o.

    Prague, 190 00, Czechia

  • Pulmo s.r.o.,

    Prešov, 080 01, Slovakia

  • RCMed Oddział Sochaczew

    Sochaczew, 96-500, Poland

  • Research Center for Medical Studies

    Berlin, 10717, Germany

  • Reserka LLC

    Miami, Florida, 33176, United States

  • SHATPD Dr. Treyman

    Veliko Tarnovo, 5003, Bulgaria

  • SHATPPD Vratsa

    Vratsa, 3000, Bulgaria

  • San Marcus Research

    Miami Lakes, Florida, 33015, United States

  • Sana Medical Center

    Bucharest, 11025, Romania

  • Sanyuudo Hospital

    Yamagata, 992-0045, Japan

  • Sc. Centrul Medical Sana Srl

    Brasov, 500440, Romania

  • Siteworks - Prüfzentrum Schleswig | RespiRatio

    Schleswig, 24837, Germany

  • Soejima Clinic

    Fukuoka, 812-0016, Japan

  • Sones Medical Research

    Miami, Florida, 33133, United States

  • Spital de Pneumologie dr Lavinia Davidescu Oradea

    Oradea, 410163, Romania

  • Suncoast Research Group, LLC dba Flourish Research

    Miami, Florida, 33135, United States

  • The Medici Medical Research, LLC

    Hollywood, Florida, 33021, United States

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, 193-0998, Japan

  • Treasure Coast Medical Research Group

    Port Saint Lucie, Florida, 34986, United States

  • Velocity Clinical Research Wiesbaden

    Wiesbaden, 65189, Germany

  • Velocity High Wycombe

    High Wycombe, HP11 2QW, United Kingdom

  • Vseobecna ambulancia pre dospelych

    Košice, 040 01, Slovakia

  • Yokohama Minoru Clinic

    Yokohama, 232-0064, Japan

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Other studies related to the condition(s) this trial covers.