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NCT07108166NARecruiting

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

Philip Morris Products S.A.

Start Date

4/2/2025

Completion Date

11/1/2026

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.

Eligibility Criteria

Age Range: 40 years to No maximum

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.

Interventions

OTHER

Cigarette

OTHER

THS

Interested in This Trial?

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Conditions

COPDSmokingTobacco Use

Locations

Clinical Research of West Florida, Inc.

Clearwater, Florida 33765

United States

Florida International Medical Research

Coral Gables, Florida 33134

United States

Alfa Medical Research

Davie, Florida 33024

United States

Omega Research Debary, LLC

DeBary, Florida 32713

United States

D&H Doral Research Center

Doral, Florida 33122

United States

Felicidad Med Research

Hialeah, Florida 33012

United States

New Life Medical Research Center, Inc

Hialeah, Florida 33012

United States

The Medici Medical Research, LLC

Hollywood, Florida 33021

United States

D&H Pompano Research Center

Margate, Florida 33063

United States

Med-Care Research Corp

Miami, Florida 33125

United States

EMDA Clincal Research

Miami, Florida 33126

United States

Sones Medical Research

Miami, Florida 33133

United States

Suncoast Research Group, LLC dba Flourish Research

Miami, Florida 33135

United States

Melgar-Caro Medcenter and Community Research

Miami, Florida 33145

United States

D&H National Research Center- Miami

Miami, Florida 33155.0

United States

Biomed Research & Medical Center.Llc

Miami, Florida 33156

United States

Global Health Clinical Trials Corp.

Miami, Florida 33165

United States

Professional Research Center Inc

Miami, Florida 33172

United States

Newgen Health Group

Miami, Florida 33176

United States

Reserka LLC

Miami, Florida 33176

United States

Pharma Medical Innovations

Miami Lakes, Florida 33014

United States

San Marcus Research

Miami Lakes, Florida 33015

United States

MedQuest Translational Sciences LLC

Miami Lakes, Florida 33016.0

United States

Advanced Research Institute, Inc

New Port Richey, Florida 34653

United States

Harmony Clinical Research

North Miami Beach, Florida 33162

United States

Central Florida Pulmonary Group, P.A.

Orlando, Florida 32803

United States

Comprehensive Medical & Research Center

Plantation, Florida 33317

United States

CDC Research Institute

Port Saint Lucie, Florida 34952

United States

Treasure Coast Medical Research Group

Port Saint Lucie, Florida 34986

United States

Advanced Research Institute, Inc

St. Petersburg, Florida 33710

United States

D&H Tamarac Research Center

Tamarac, Florida 33321

United States

Metropolitan Clinical Research Center

Tamarac, Florida 33321

United States

Optimum Clinical Trial Group

Tampa, Florida 33612

United States

Guardian Angel

Tampa, Florida 33614

United States

Pivotal Research Solutions

Stonecrest, Georgia 30038

United States

Premier Pulmonary Critical Care and Sleep Medicine

Denison, Texas 75020

United States

El Paso Pulmonary Association

El Paso, Texas 79902

United States

HDH Research Inc

Houston, Texas 77022

United States

Prolato Research LLC.

Houston, Texas 77054

United States

Houston Pulmonary Medicine Associates

Houston, Texas 77089

United States

Pioneer Research Solutions Inc

Houston, Texas 77099

United States

Accurate Clinical Research, Inc.

Humble, Texas 77338

United States

Metroplex Pulmonary & Sleep Center

McKinney, Texas 75069

United States

LinQ Research, LLC

Pearland, Texas 77584

United States

Element Research Group

San Antonio, Texas 78258

United States

Medrasa Clinical Research

Sherman, Texas 75092

United States

MHAT Rahila Angelova

Pernik, 2300

Bulgaria

MHAT Lyulin EAD

Sofia, 1336

Bulgaria

Medical Center Hera EOOD

Sofia, 1510

Bulgaria

Medical Center Pulmovision Ltd

Sofia, 1756

Bulgaria

SHATPD Dr. Treyman

Veliko Tarnovo, 5003

Bulgaria

SHATPPD Vratsa

Vratsa, 3000

Bulgaria

MUDr. Otakar Hokynar - plicni ambulance

Kralupy nad Vltavou, 278 01

Czechia

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

Olomouc, 779 00

Czechia

CCR Ostrava s.r.o.

Ostrava, 702 00

Czechia

Medicon a.s.

Prague, 140 00

Czechia

Prvni plicni ambulance s.r.o.

Prague, 190 00

Czechia

Pneumologie Varnsdorf s.r.o.

Varnsdorf, 407 47

Czechia

Klinische Forschung Berlin Mitte /Pratia Germany

Berlin, 10117

Germany

Research Center for Medical Studies

Berlin, 10717

Germany

Klifeck GmbH

Delitzsch, 4509

Germany

Klinische Forschung Hannover-Mitte GmbH /Pratia Germany

Hanover, 30159

Germany

Klinische Forschung Karlsruhe GmbH / Pratio Germany

Karlsruhe, 76137

Germany

Facharzt für Innere Medizin und Pneumologie

Leipzig, 04157

Germany

POIS Sachsen GmbH

Leipzig, 4509

Germany

Ballenberger Freytag Wenisch - Institut für klinische Forschung GmbH

Neu-Isenburg, 63263

Germany

FutureMeds Frankfurt

Offenbach, 63065

Germany

Praxis Reinfeld Mitte

Reinfeld, 23858

Germany

Siteworks - Prüfzentrum Schleswig | RespiRatio

Schleswig, 24837

Germany

BAG Peter Fried / Dr. med. Roman Rubin

Wiesbaden, 65183

Germany

Velocity Clinical Research Wiesbaden

Wiesbaden, 65189

Germany

Lungenpraxis Witten

Witten, 58452

Germany

Soejima Clinic

Fukuoka, 812-0016

Japan

Maebashi North Hospital

Gunma, 371-0054

Japan

Akashi Medical Center

Hyōgo, 674-0063

Japan

Fukuwa Clinic

Tokyo, 104-0031

Japan

Kouwa Clinic

Tokyo, 170-0003

Japan

Tokyo Medical University Hachioji Medical Center

Tokyo, 193-0998

Japan

Sanyuudo Hospital

Yamagata, 992-0045

Japan

Yokohama Minoru Clinic

Yokohama, 232-0064

Japan

Clinical Research Hospital Tokyo

Yotsuya, 160-0004

Japan

Centrum Medycyny Oddechowej Mroz Spolka jawna

Bialystok, 15-044

Poland

BioResearch Group Sp. z.o.o

Kajetany, 05-830

Poland

FutureMeds Krakowskie Centrum Medyczne

Krakow, 31-501

Poland

FutureMeds Łódź

Lodz, 91-363

Poland

RCMed Oddział Sochaczew

Sochaczew, 96-500

Poland

FutureMeds Warszawa Centrum

Warsaw, 00-215

Poland

FutureMeds Targówek

Warsaw, 03-291

Poland

Dobrostan

Wroclaw, 53-301

Poland

FutureMeds Wrocław

Wroclaw, 53-673

Poland

Ames Research Center

Bragadiru, 077025

Romania

Sc. Centrul Medical Sana Srl

Brasov, 500440

Romania

Sana Medical Center

Bucharest, 11025

Romania

Ames Research Center

Calarasi, 910103

Romania

Clintrial Medical Centre SRL

Dobrosloveni, 237143

Romania

Spital de Pneumologie dr Lavinia Davidescu Oradea

Oradea, 410163

Romania

AI Clinical Research

Sibiu, 550082

Romania

PANACEUM s.r.o.

Košice, 040 01

Slovakia

Vseobecna ambulancia pre dospelych

Košice, 040 01

Slovakia

Pulmo s.r.o.,

Prešov, 080 01

Slovakia

Plucna ambulancia Hrebenar S.R.O.

Spišská Nová Ves, 5201

Slovakia

Alergia s. r. o.

Topoľčany, 955 01

Slovakia

Panthera Biopartners

Enfield, EN3 4GS

United Kingdom

Panthera Biopartners

Glasgow, G51 4TF

United Kingdom

Velocity High Wycombe

High Wycombe, HP11 2QW

United Kingdom

4 Medical Clinical Solutions (4MCS)

London, IG1 4HP

United Kingdom

4 Medical Clinical Solutions (4MCS)

Manchester, M27 8FF

United Kingdom

FutureMeds Liverpool

Metropolitan Borough of Wirral, CH62 6EE

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