RecruitingCOPDSmokingTobacco Use
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
Eligible age
40+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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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.
Sponsor: Philip Morris Products S.A.
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.
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).
Where it's recruiting
Source: ClinicalTrials.gov · NCT07108166 · last updated 2026-06-15