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

NCT07108166 | Active Not Recruiting

• 1 other identifier: P1-FAF-16
• Study Type: interventional
• Target: 290
• Locations: 9 countries
• Sites: 112

Brief 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.

Conditions

COPD; Smoking; Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Reduction in 24-hour cough frequency

  To demonstrate a change in 24-hour cough frequency in COPD patients with chronic bronchitis switching from cigarette (CIG) to THS compared to those who continue to smoke CIG.

  Measured from start of product use to end of week 24 (end of the exposure period).

Secondary Outcomes (13)

• Changes in lung function (from Baseline in FEV1 post-bronchodilator)

  Measured from start of product use to end of week 24 (end of the exposure period).

• Changes in the 24-hour cough frequency over time

  Measured from start of product use to 12 weeks, at the end of weeks 1, 4, and 12.

• Percentage of patients with a change in 24-hour cough frequency over time

  Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24

• Changes in the Cough Quality of Life Questionnaire (CQLQ) on chronic cough

  Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.

• Changes in cough severity over time

  Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.

Study Arms (2)

Cigarette

ACTIVE COMPARATOR

Other: Cigarette

THS

ACTIVE COMPARATOR

Other: THS

Interventions

Cigarette OTHER

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

Cigarette

THS OTHER

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

THS

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (112)

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765, United States

Location

Florida International Medical Research

Coral Gables, Florida, 33134, United States

Location

Alfa Medical Research

Davie, Florida, 33024, United States

Location

Omega Research Debary, LLC

DeBary, Florida, 32713, United States

Location

D&H Doral Research Center

Doral, Florida, 33122, United States

Location

Felicidad Med Research

Hialeah, Florida, 33012, United States

Location

New Life Medical Research Center, Inc

Hialeah, Florida, 33012, United States

Location

The Medici Medical Research, LLC

Hollywood, Florida, 33021, United States

Location

D&H Pompano Research Center

Margate, Florida, 33063, United States

Location

Med-Care Research Corp

Miami, Florida, 33125, United States

Location

EMDA Clincal Research

Miami, Florida, 33126, United States

Location

Sones Medical Research

Miami, Florida, 33133, United States

Location

Suncoast Research Group, LLC dba Flourish Research

Miami, Florida, 33135, United States

Location

Melgar-Caro Medcenter and Community Research

Miami, Florida, 33145, United States

Location

D&H National Research Center- Miami

Miami, Florida, 33155.0, United States

Location

Biomed Research & Medical Center.Llc

Miami, Florida, 33156, United States

Location

Global Health Clinical Trials Corp.

Miami, Florida, 33165, United States

Location

Professional Research Center Inc

Miami, Florida, 33172, United States

Location

Newgen Health Group

Miami, Florida, 33176, United States

Location

Reserka LLC

Miami, Florida, 33176, United States

Location

Pharma Medical Innovations

Miami Lakes, Florida, 33014, United States

Location

San Marcus Research

Miami Lakes, Florida, 33015, United States

Location

MedQuest Translational Sciences LLC

Miami Lakes, Florida, 33016.0, United States

Location

Advanced Research Institute, Inc

New Port Richey, Florida, 34653, United States

Location

Harmony Clinical Research

North Miami Beach, Florida, 33162, United States

Location

Central Florida Pulmonary Group, P.A.

Orlando, Florida, 32803, United States

Location

Comprehensive Medical & Research Center

Plantation, Florida, 33317, United States

Location

CDC Research Institute

Port Saint Lucie, Florida, 34952, United States

Location

Treasure Coast Medical Research Group

Port Saint Lucie, Florida, 34986, United States

Location

Advanced Research Institute, Inc

St. Petersburg, Florida, 33710, United States

Location

D&H Tamarac Research Center

Tamarac, Florida, 33321, United States

Location

Metropolitan Clinical Research Center

Tamarac, Florida, 33321, United States

Location

Optimum Clinical Trial Group

Tampa, Florida, 33612, United States

Location

Guardian Angel

Tampa, Florida, 33614, United States

Location

Pivotal Research Solutions

Stonecrest, Georgia, 30038, United States

Location

Premier Pulmonary Critical Care and Sleep Medicine

Denison, Texas, 75020, United States

Location

El Paso Pulmonary Association

El Paso, Texas, 79902, United States

Location

HDH Research Inc

Houston, Texas, 77022, United States

Location

Prolato Research LLC.

Houston, Texas, 77054, United States

Location

Houston Pulmonary Medicine Associates

Houston, Texas, 77089, United States

Location

Pioneer Research Solutions Inc

Houston, Texas, 77099, United States

Location

Accurate Clinical Research, Inc.

Humble, Texas, 77338, United States

Location

Metroplex Pulmonary & Sleep Center

McKinney, Texas, 75069, United States

Location

LinQ Research, LLC

Pearland, Texas, 77584, United States

Location

Element Research Group

San Antonio, Texas, 78258, United States

Location

Medrasa Clinical Research

Sherman, Texas, 75092, United States

Location

MHAT Rahila Angelova

Pernik, 2300, Bulgaria

Location

MHAT Lyulin EAD

Sofia, 1336, Bulgaria

Location

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

Location

Medical Center Pulmovision Ltd

Sofia, 1756, Bulgaria

Location

SHATPD Dr. Treyman

Veliko Tarnovo, 5003, Bulgaria

Location

SHATPPD Vratsa

Vratsa, 3000, Bulgaria

Location

MUDr. Otakar Hokynar - plicni ambulance

Kralupy nad Vltavou, 278 01, Czechia

Location

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

Olomouc, 779 00, Czechia

Location

CCR Ostrava s.r.o.

Ostrava, 702 00, Czechia

Location

Medicon a.s.

Prague, 140 00, Czechia

Location

Prvni plicni ambulance s.r.o.

Prague, 190 00, Czechia

Location

Pneumologie Varnsdorf s.r.o.

Varnsdorf, 407 47, Czechia

Location

Klinische Forschung Berlin Mitte /Pratia Germany

Berlin, 10117, Germany

Location

Research Center for Medical Studies

Berlin, 10717, Germany

Location

Klifeck GmbH

Delitzsch, 4509, Germany

Location

Klinische Forschung Hannover-Mitte GmbH /Pratia Germany

Hanover, 30159, Germany

Location

Klinische Forschung Karlsruhe GmbH / Pratio Germany

Karlsruhe, 76137, Germany

Location

Facharzt für Innere Medizin und Pneumologie

Leipzig, 04157, Germany

Location

POIS Sachsen GmbH

Leipzig, 4509, Germany

Location

Ballenberger Freytag Wenisch - Institut für klinische Forschung GmbH

Neu-Isenburg, 63263, Germany

Location

FutureMeds Frankfurt

Offenbach, 63065, Germany

Location

Praxis Reinfeld Mitte

Reinfeld, 23858, Germany

Location

Siteworks - Prüfzentrum Schleswig | RespiRatio

Schleswig, 24837, Germany

Location

BAG Peter Fried / Dr. med. Roman Rubin

Wiesbaden, 65183, Germany

Location

Velocity Clinical Research Wiesbaden

Wiesbaden, 65189, Germany

Location

Lungenpraxis Witten

Witten, 58452, Germany

Location

Soejima Clinic

Fukuoka, 812-0016, Japan

Location

Maebashi North Hospital

Gunma, 371-0054, Japan

Location

Akashi Medical Center

Hyōgo, 674-0063, Japan

Location

Fukuwa Clinic

Tokyo, 104-0031, Japan

Location

Kouwa Clinic

Tokyo, 170-0003, Japan

Location

Tokyo Medical University Hachioji Medical Center

Tokyo, 193-0998, Japan

Location

Sanyuudo Hospital

Yamagata, 992-0045, Japan

Location

Yokohama Minoru Clinic

Yokohama, 232-0064, Japan

Location

Clinical Research Hospital Tokyo

Yotsuya, 160-0004, Japan

Location

Centrum Medycyny Oddechowej Mroz Spolka jawna

Bialystok, 15-044, Poland

Location

BioResearch Group Sp. z.o.o

Kajetany, 05-830, Poland

Location

FutureMeds Krakowskie Centrum Medyczne

Krakow, 31-501, Poland

Location

FutureMeds Łódź

Lodz, 91-363, Poland

Location

RCMed Oddział Sochaczew

Sochaczew, 96-500, Poland

Location

FutureMeds Warszawa Centrum

Warsaw, 00-215, Poland

Location

FutureMeds Targówek

Warsaw, 03-291, Poland

Location

Dobrostan

Wroclaw, 53-301, Poland

Location

FutureMeds Wrocław

Wroclaw, 53-673, Poland

Location

Ames Research Center

Bragadiru, 077025, Romania

Location

Sc. Centrul Medical Sana Srl

Brasov, 500440, Romania

Location

Sana Medical Center

Bucharest, 11025, Romania

Location

Ames Research Center

Calarasi, 910103, Romania

Location

Clintrial Medical Centre SRL

Dobrosloveni, 237143, Romania

Location

Spital de Pneumologie dr Lavinia Davidescu Oradea

Oradea, 410163, Romania

Location

AI Clinical Research

Sibiu, 550082, Romania

Location

PANACEUM s.r.o.

Košice, 040 01, Slovakia

Location

Vseobecna ambulancia pre dospelych

Košice, 040 01, Slovakia

Location

Pulmo s.r.o.,

Prešov, 080 01, Slovakia

Location

Plucna ambulancia Hrebenar S.R.O.

Spišská Nová Ves, 5201, Slovakia

Location

Alergia s. r. o.

Topoľčany, 955 01, Slovakia

Location

Panthera Biopartners

Enfield, EN3 4GS, United Kingdom

Location

Panthera Biopartners

Glasgow, G51 4TF, United Kingdom

Location

Velocity High Wycombe

High Wycombe, HP11 2QW, United Kingdom

Location

4 Medical Clinical Solutions (4MCS)

London, IG1 4HP, United Kingdom

Location

4 Medical Clinical Solutions (4MCS)

Manchester, M27 8FF, United Kingdom

Location

FutureMeds Liverpool

Metropolitan Borough of Wirral, CH62 6EE, United Kingdom

Location

Panthera Biopartners

Preston, PR2 9QB, United Kingdom

Location

Panthera Biopartners

Rochdale, OL11 4AU, United Kingdom

Location

Panthera Biopartners

Sheffield, S2 5FX, United Kingdom

Location

Panthera Biopartners

York, YO24 4LJ, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking; Tobacco Use

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Xavier Jaumont, MD

  Philip Morris Products S.A.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: August 6, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-03

Locations

SL (5); BU (6); US (46); PL (9); RO (7); DE (14); JP (9); CZ (6); GB (10)