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

Recruiting now · Not applicable

Conditions studied: COPD, Smoking, Tobacco Use

In brief

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.

Key facts

Study ID

NCT07108166

Run by

Philip Morris Products S.A.

People needed

290

Starts

2025-04-02

Expected to finish

2026-11-01

Last updated by the study team

2026-06-15

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Clintrial Medical Centre SRL — Dobrosloveni, Romania (enrolling)
• Alfa Medical Research — Davie, Florida, United States
• Biomed Research & Medical Center.Llc — Miami, Florida, United States
• D&H Doral Research Center — Doral, Florida, United States
• Felicidad Med Research — Hialeah, Florida, United States
• New Life Medical Research Center, Inc — 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
• Omega Research Debary, LLC — DeBary, 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
• Florida International Medical Research — Coral Gables, Florida, United States

Full record on ClinicalTrials.gov

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