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Clinical Trials in the USA / NCT07108166
Active, not recruiting Not applicable

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

NCT07108166 · tracked via the Priya Life Science USA tracker
Sponsor
Philip Morris Products S.A.
Phase
Not applicable
Started
2025-04-02
Last updated
2026-08-31

Condition(s) studied

COPDSmokingTobacco Use

Investigational drug(s) / intervention(s)

CigaretteTHS

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

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

Study 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

Sex
ALL
Min age
40 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (112)

FacilityCityRegionStatus
Clinical Research of West Florida, Inc. Clearwater Florida
Florida International Medical Research Coral Gables Florida
Alfa Medical Research Davie Florida
Omega Research Debary, LLC DeBary Florida
D&H Doral Research Center Doral Florida
Felicidad Med Research Hialeah Florida
New Life Medical Research Center, Inc Hialeah Florida
The Medici Medical Research, LLC Hollywood Florida
D&H Pompano Research Center Margate Florida
Med-Care Research Corp Miami Florida
EMDA Clincal Research Miami Florida
Sones Medical Research Miami Florida
Suncoast Research Group, LLC dba Flourish Research Miami Florida
Melgar-Caro Medcenter and Community Research Miami Florida
D&H National Research Center- Miami Miami Florida
Biomed Research & Medical Center.Llc Miami Florida
Global Health Clinical Trials Corp. Miami Florida
Professional Research Center Inc Miami Florida
Newgen Health Group Miami Florida
Reserka LLC Miami Florida
Pharma Medical Innovations Miami Lakes Florida
San Marcus Research Miami Lakes Florida
MedQuest Translational Sciences LLC Miami Lakes Florida
Advanced Research Institute, Inc New Port Richey Florida
Harmony Clinical Research North Miami Beach Florida
Central Florida Pulmonary Group, P.A. Orlando Florida
Comprehensive Medical & Research Center Plantation Florida
CDC Research Institute Port Saint Lucie Florida
Treasure Coast Medical Research Group Port Saint Lucie Florida
Advanced Research Institute, Inc St. Petersburg Florida
D&H Tamarac Research Center Tamarac Florida
Metropolitan Clinical Research Center Tamarac Florida
Optimum Clinical Trial Group Tampa Florida
Guardian Angel Tampa Florida
Pivotal Research Solutions Stonecrest Georgia
Premier Pulmonary Critical Care and Sleep Medicine Denison Texas
El Paso Pulmonary Association El Paso Texas
HDH Research Inc Houston Texas
Prolato Research LLC. Houston Texas
Houston Pulmonary Medicine Associates Houston Texas

+ 72 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07108166 on ClinicalTrials.gov ↗ ← All trials in the USA