RecruitingRecruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
NCT07108166 · Philip Morris Products S.A.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
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
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.
Study design
Enrollment target: 290 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-02
Estimated completion: 2026-11
Last updated: 2026-06-15
Interventions
Other: CigaretteOther: THS
Primary outcomes
- • Reduction in 24-hour cough frequency (Measured from start of product use to end of week 24 (end of the exposure period).)
Sponsor
Philip Morris Products S.A. · industry
Contacts & investigators
ContactXavier Jaumont, MD · contact · Xavier.Jaumont@pmi.com · +41582421111
InvestigatorXavier Jaumont, MD · study_chair, Philip Morris Products S.A.
All locations (112)
Clinical Research of West Florida, Inc.Active Not Recruiting
Clearwater, Florida, United States
Florida International Medical ResearchActive Not Recruiting
Coral Gables, Florida, United States
Alfa Medical ResearchActive Not Recruiting
Davie, Florida, United States
Omega Research Debary, LLCActive Not Recruiting
DeBary, Florida, United States
D&H Doral Research CenterActive Not Recruiting
Doral, Florida, United States
Felicidad Med ResearchActive Not Recruiting
Hialeah, Florida, United States
New Life Medical Research Center, IncNot Yet Recruiting
Hialeah, Florida, United States
The Medici Medical Research, LLCActive Not Recruiting
Hollywood, Florida, United States
D&H Pompano Research CenterActive Not Recruiting
Margate, Florida, United States
Med-Care Research CorpActive Not Recruiting
Miami, Florida, United States
EMDA Clincal ResearchActive Not Recruiting
Miami, Florida, United States
Sones Medical ResearchActive Not Recruiting
Miami, Florida, United States
Suncoast Research Group, LLC dba Flourish ResearchActive Not Recruiting
Miami, Florida, United States
Melgar-Caro Medcenter and Community ResearchActive Not Recruiting
Miami, Florida, United States
D&H National Research Center- MiamiActive Not Recruiting
Miami, Florida, United States
Biomed Research & Medical Center.LlcActive Not Recruiting
Miami, Florida, United States
Global Health Clinical Trials Corp.Active Not Recruiting
Miami, Florida, United States
Professional Research Center IncActive Not Recruiting
Miami, Florida, United States
Newgen Health GroupActive Not Recruiting
Miami, Florida, United States
Reserka LLCActive Not Recruiting
Miami, Florida, United States
Pharma Medical InnovationsActive Not Recruiting
Miami Lakes, Florida, United States
San Marcus ResearchActive Not Recruiting
Miami Lakes, Florida, United States
MedQuest Translational Sciences LLCActive Not Recruiting
Miami Lakes, Florida, United States
Advanced Research Institute, IncActive Not Recruiting
New Port Richey, Florida, United States
Harmony Clinical ResearchActive Not Recruiting
North Miami Beach, Florida, United States
Central Florida Pulmonary Group, P.A.Active Not Recruiting
Orlando, Florida, United States
Comprehensive Medical & Research CenterActive Not Recruiting
Plantation, Florida, United States
CDC Research InstituteActive Not Recruiting
Port Saint Lucie, Florida, United States
Treasure Coast Medical Research GroupActive Not Recruiting
Port Saint Lucie, Florida, United States
Advanced Research Institute, IncActive Not Recruiting
St. Petersburg, Florida, United States
D&H Tamarac Research CenterActive Not Recruiting
Tamarac, Florida, United States
Metropolitan Clinical Research CenterActive Not Recruiting
Tamarac, Florida, United States
Optimum Clinical Trial GroupActive Not Recruiting
Tampa, Florida, United States
Guardian AngelActive Not Recruiting
Tampa, Florida, United States
Pivotal Research SolutionsActive Not Recruiting
Stonecrest, Georgia, United States
Premier Pulmonary Critical Care and Sleep MedicineActive Not Recruiting
Denison, Texas, United States
El Paso Pulmonary AssociationActive Not Recruiting
El Paso, Texas, United States
HDH Research IncActive Not Recruiting
Houston, Texas, United States
Prolato Research LLC.Active Not Recruiting
Houston, Texas, United States
Houston Pulmonary Medicine AssociatesActive Not Recruiting
Houston, Texas, United States
Pioneer Research Solutions IncActive Not Recruiting
Houston, Texas, United States
Accurate Clinical Research, Inc.Active Not Recruiting
Humble, Texas, United States
Metroplex Pulmonary & Sleep CenterActive Not Recruiting
McKinney, Texas, United States
LinQ Research, LLCActive Not Recruiting
Pearland, Texas, United States
Element Research GroupActive Not Recruiting
San Antonio, Texas, United States
Medrasa Clinical ResearchActive Not Recruiting
Sherman, Texas, United States
MHAT Rahila AngelovaActive Not Recruiting
Pernik, Bulgaria
MHAT Lyulin EADActive Not Recruiting
Sofia, Bulgaria
Medical Center Hera EOODNot Yet Recruiting
Sofia, Bulgaria
Medical Center Pulmovision LtdActive Not Recruiting
Sofia, Bulgaria
SHATPD Dr. TreymanNot Yet Recruiting
Veliko Tarnovo, Bulgaria
SHATPPD VratsaActive Not Recruiting
Vratsa, Bulgaria
MUDr. Otakar Hokynar - plicni ambulanceActive Not Recruiting
Kralupy nad Vltavou, Czechia
Ordinace pro tbc a respirační nemoci s.r.o.Active Not Recruiting
Olomouc, Czechia
CCR Ostrava s.r.o.Active Not Recruiting
Ostrava, Czechia
Medicon a.s.Active Not Recruiting
Prague, Czechia
Prvni plicni ambulance s.r.o.Active Not Recruiting
Prague, Czechia
Pneumologie Varnsdorf s.r.o.Active Not Recruiting
Varnsdorf, Czechia
Klinische Forschung Berlin Mitte /Pratia GermanyActive Not Recruiting
Berlin, Germany
Research Center for Medical StudiesActive Not Recruiting
Berlin, Germany
Klifeck GmbHActive Not Recruiting
Delitzsch, Germany
Klinische Forschung Hannover-Mitte GmbH /Pratia GermanyActive Not Recruiting
Hanover, Germany
Klinische Forschung Karlsruhe GmbH / Pratio GermanyActive Not Recruiting
Karlsruhe, Germany
Facharzt für Innere Medizin und PneumologieActive Not Recruiting
Leipzig, Germany
POIS Sachsen GmbHActive Not Recruiting
Leipzig, Germany
Ballenberger Freytag Wenisch - Institut für klinische Forschung GmbHActive Not Recruiting
Neu-Isenburg, Germany
FutureMeds FrankfurtActive Not Recruiting
Offenbach, Germany
Praxis Reinfeld MitteActive Not Recruiting
Reinfeld, Germany
Siteworks - Prüfzentrum Schleswig | RespiRatioActive Not Recruiting
Schleswig, Germany
BAG Peter Fried / Dr. med. Roman RubinActive Not Recruiting
Wiesbaden, Germany
Velocity Clinical Research WiesbadenActive Not Recruiting
Wiesbaden, Germany
Lungenpraxis WittenActive Not Recruiting
Witten, Germany
Soejima ClinicActive Not Recruiting
Fukuoka, Japan
Maebashi North HospitalActive Not Recruiting
Gunma, Japan
Akashi Medical CenterActive Not Recruiting
Hyōgo, Japan
Fukuwa ClinicActive Not Recruiting
Tokyo, Japan
Kouwa ClinicActive Not Recruiting
Tokyo, Japan
Tokyo Medical University Hachioji Medical CenterActive Not Recruiting
Tokyo, Japan
Sanyuudo HospitalActive Not Recruiting
Yamagata, Japan
Yokohama Minoru ClinicActive Not Recruiting
Yokohama, Japan
Clinical Research Hospital TokyoActive Not Recruiting
Yotsuya, Japan
Centrum Medycyny Oddechowej Mroz Spolka jawnaActive Not Recruiting
Bialystok, Poland
BioResearch Group Sp. z.o.oActive Not Recruiting
Kajetany, Poland
FutureMeds Krakowskie Centrum MedyczneActive Not Recruiting
Krakow, Poland
FutureMeds ŁódźActive Not Recruiting
Lodz, Poland
RCMed Oddział SochaczewActive Not Recruiting
Sochaczew, Poland
FutureMeds Warszawa CentrumActive Not Recruiting
Warsaw, Poland
FutureMeds TargówekActive Not Recruiting
Warsaw, Poland
DobrostanActive Not Recruiting
Wroclaw, Poland
FutureMeds WrocławActive Not Recruiting
Wroclaw, Poland
Ames Research CenterActive Not Recruiting
Bragadiru, Romania
Sc. Centrul Medical Sana SrlActive Not Recruiting
Brasov, Romania
Sana Medical CenterActive Not Recruiting
Bucharest, Romania
Ames Research CenterActive Not Recruiting
Calarasi, Romania
Clintrial Medical Centre SRLRecruiting
Dobrosloveni, Romania
Spital de Pneumologie dr Lavinia Davidescu OradeaActive Not Recruiting
Oradea, Romania
AI Clinical ResearchNot Yet Recruiting
Sibiu, Romania
PANACEUM s.r.o.Not Yet Recruiting
Košice, Slovakia
Vseobecna ambulancia pre dospelychNot Yet Recruiting
Košice, Slovakia
Pulmo s.r.o.,Active Not Recruiting
Prešov, Slovakia
Plucna ambulancia Hrebenar S.R.O.Active Not Recruiting
Spišská Nová Ves, Slovakia
Alergia s. r. o.Active Not Recruiting
Topoľčany, Slovakia
Panthera BiopartnersActive Not Recruiting
Enfield, United Kingdom
Panthera BiopartnersActive Not Recruiting
Glasgow, United Kingdom
Velocity High WycombeActive Not Recruiting
High Wycombe, United Kingdom
4 Medical Clinical Solutions (4MCS)Active Not Recruiting
London, United Kingdom
4 Medical Clinical Solutions (4MCS)Active Not Recruiting
Manchester, United Kingdom
FutureMeds LiverpoolActive Not Recruiting
Metropolitan Borough of Wirral, United Kingdom
Panthera BiopartnersActive Not Recruiting
Preston, United Kingdom
Panthera BiopartnersActive Not Recruiting
Rochdale, United Kingdom
Panthera BiopartnersActive Not Recruiting
Sheffield, United Kingdom
Panthera BiopartnersActive Not Recruiting
York, United Kingdom