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RECRUITING

NCT07108166

Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS

Sponsor: Philip Morris Products S.A.

View on ClinicalTrials.gov

Summary

The purpose of this randomized study is to demonstrate direct clinical benefit, i.e., observed benefits in how humans with COPD feel in terms of symptoms (e.g., cough frequency, shortness of breath, and other respiratory symptoms) and function (e.g., lung function, and six-minute walking test \[6MWT\]) after switching to THS compared to continuing to smoking cigarettes.

Official title: A Randomized, Single (Operator)-Blinded, Controlled Clinical Study for Assessing Major Symptoms and Function in Patients With Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis Who Switch From Combustible Cigarettes (CIG) to Tobacco Heating System (THS)

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

290

Start Date

2025-04-02

Completion Date

2026-11

Last Updated

2025-09-12

Healthy Volunteers

Conditions

COPD Smoking Tobacco Use

Interventions

OTHER

Cigarette

COPD patients will continue to smoke their cigarettes ad libitum, with no brand restrictions.

OTHER

THS

COPD patients will switch from cigarette smoking to ad libitum THS use, with no flavor variant restrictions.

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.

Locations (111)

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

Florida International Medical Research

Coral Gables, Florida, United States

Alfa Medical Research

Davie, Florida, United States

Omega Research Debary, LLC

DeBary, Florida, United States

D&H Doral Research Center

Doral, Florida, United States

Felicidad Med Research

Hialeah, Florida, United States

The Medici Medical Research, LLC

Hollywood, Florida, United States

D&H Pompano Research Center

Margate, Florida, United States

Med-Care Research Corp

Miami, Florida, United States

EMDA Clincal Research

Miami, Florida, United States

Sones Medical Research

Miami, Florida, United States

Suncoast Research Group, LLC dba Flourish Research

Miami, Florida, United States

Melgar-Caro Medcenter and Community Research

Miami, Florida, United States

D&H National Research Center- Miami

Miami, Florida, United States

Biomed Research & Medical Center.Llc

Miami, Florida, United States

Global Health Clinical Trials Corp.

Miami, Florida, United States

Professional Research Center Inc

Miami, Florida, United States

Newgen Health Group

Miami, Florida, United States

Reserka LLC

Miami, Florida, United States

Pharma Medical Innovations

Miami Lakes, Florida, United States

San Marcus Research

Miami Lakes, Florida, United States

MedQuest Translational Sciences LLC

Miami Lakes, Florida, United States

Advanced Research Institute, Inc

New Port Richey, Florida, United States

Harmony Clinical Research

North Miami Beach, Florida, United States

Central Florida Pulmonary Group, P.A.

Orlando, Florida, United States

Comprehensive Medical & Research Center

Plantation, Florida, United States

CDC Research Institute

Port Saint Lucie, Florida, United States

Treasure Coast Medical Research Group

Port Saint Lucie, Florida, United States

Advanced Research Institute, Inc

St. Petersburg, Florida, United States

D&H Tamarac Research Center

Tamarac, Florida, United States

Metropolitan Clinical Research Center

Tamarac, Florida, United States

Optimum Clinical Trial Group

Tampa, Florida, United States

Pivotal Research Solutions

Stonecrest, Georgia, United States

Premier Pulmonary Critical Care and Sleep Medicine

Denison, Texas, United States

El Paso Pulmonary Association

El Paso, Texas, United States

HDH Research Inc

Houston, Texas, United States

Prolato Research LLC.

Houston, Texas, United States

Houston Pulmonary Medicine Associates

Houston, Texas, United States

Pioneer Research Solutions Inc

Houston, Texas, United States

Accurate Clinical Research, Inc.

Humble, Texas, United States

Metroplex Pulmonary & Sleep Center

McKinney, Texas, United States

Element Research Group

San Antonio, Texas, United States

Medrasa Clinical Research

Sherman, Texas, United States

Pulmonics Plus

Waxahachie, Texas, United States

MHAT Rahila Angelova

Pernik, Bulgaria

MHAT Lyulin EAD

Sofia, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

Medical Center Pulmovision Ltd

Sofia, Bulgaria

SHATPD Dr. Treyman

Veliko Tarnovo, Bulgaria

SHATPPD Vratsa

Vratsa, Bulgaria

MUDr. Otakar Hokynar - plicni ambulance

Kralupy nad Vltavou, Czechia

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

Olomouc, Czechia

CCR Ostrava s.r.o.

Ostrava, Czechia

Medicon a.s.

Prague, Czechia

Prvni plicni ambulance s.r.o.

Prague, Czechia

Pneumologie Varnsdorf s.r.o.

Varnsdorf, Czechia

Klinische Forschung Berlin Mitte /Pratia Germany

Berlin, Germany

Research Center for Medical Studies

Berlin, Germany

Klifeck GmbH

Delitzsch, Germany

Klinische Forschung Hannover-Mitte GmbH /Pratia Germany

Hanover, Germany

Klinische Forschung Karlsruhe GmbH / Pratio Germany

Karlsruhe, Germany

Facharzt für Innere Medizin und Pneumologie

Leipzig, Germany

POIS Sachsen GmbH

Leipzig, Germany

Ballenberger Freytag Wenisch - Institut für klinische Forschung GmbH

Neu-Isenburg, Germany

FutureMeds Frankfurt

Offenbach, Germany

Praxis Reinfeld Mitte

Reinfeld, Germany

Siteworks - Prüfzentrum Schleswig | RespiRatio

Schleswig, Germany

BAG Peter Fried / Dr. med. Roman Rubin

Wiesbaden, Germany

Velocity Clinical Research Wiesbaden

Wiesbaden, Germany

Lungenpraxis Witten

Witten, Germany

Soejima Clinic

Fukuoka, Japan

JCHO Nihonmatsu Hospital

Fukushima, Japan

Maebashi North Hospital

Gunma, Japan

Akashi Medical Center

Hyōgo, Japan

Fukuwa Clinic

Tokyo, Japan

Kouwa Clinic

Tokyo, Japan

Sanyuudo Hospital

Yamagata, Japan

Yokohama Minoru Clinic

Yokohama, Japan

Clinical Research Hospital Tokyo

Yotsuya, Japan

Centrum Medycyny Oddechowej Mroz Spolka jawna

Bialystok, Poland

BioResearch Group Sp. z.o.o

Kajetany, Poland

FutureMeds Krakowskie Centrum Medyczne

Krakow, Poland

FutureMeds Łódź

Lodz, Poland

AmiCare Centrum Medyczne

Lodz, Poland

RCMed Oddział Sochaczew

Sochaczew, Poland

FutureMeds Warszawa Centrum

Warsaw, Poland

FutureMeds Targówek

Warsaw, Poland

Dobrostan

Wroclaw, Poland

FutureMeds Wrocław

Wroclaw, Poland

Ames Research Center

Bragadiru, Romania

Sc. Centrul Medical Sana Srl

Brasov, Romania

Sana Medical Center

Bucharest, Romania

Ames Research Center

Călăraşi, Romania

Clintrial Medical Centre SRL

Dobrosloveni, Romania

Spital de Pneumologie dr Lavinia Davidescu Oradea

Oradea, Romania

AI Clinical Research

Sibiu, Romania

PANACEUM s.r.o.

Košice, Slovakia

Vseobecna ambulancia pre dospelych

Košice, Slovakia

Pulmo s.r.o.,

Prešov, Slovakia

Plucna ambulancia Hrebenar S.R.O.

Spišská Nová Ves, Slovakia

Alergia s. r. o.

Topoľčany, Slovakia

Panthera Biopartners

Enfield, United Kingdom

Panthera Biopartners

Glasgow, United Kingdom

Velocity High Wycombe

High Wycombe, United Kingdom

4 Medical Clinical Solutions (4MCS)

London, United Kingdom

4 Medical Clinical Solutions (4MCS)

Manchester, United Kingdom

FutureMeds Liverpool

Metropolitan Borough of Wirral, United Kingdom

Panthera Biopartners

Preston, United Kingdom

Panthera Biopartners

Rochdale, United Kingdom

Panthera Biopartners

Sheffield, United Kingdom

Panthera Biopartners

York, United Kingdom

Clinical Research Directory

Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (111)