RecruitingNot Applicable

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

United States, Bulgaria, Czechia290 participantsStarted 2025-04-02

Plain-language 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.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is studying whether switching from cigarettes to a heated tobacco product affects cough frequency in people with COPD and chronic bronchitis — given that I still have COPD regardless of which product I use, is there any risk that switching to a heated tobacco product could still harm my lungs or make my condition worse?
2Since this trial is listed as Phase NA, which often means it's observational or non-interventional rather than a traditional drug trial, can you help me understand what that means for my safety and what I'd actually be asked to do if I took part?
3The trial is measuring 24-hour cough frequency as its main outcome — does a reduction in coughing necessarily mean my underlying COPD is improving, or could it mask other important changes in my lung health that we should be monitoring?
4Would participating in this trial mean I'm continuing to use tobacco products rather than quitting entirely, and would that conflict with the standard treatment approach you'd normally recommend for my COPD?
5Are there proven, standard treatments for COPD and chronic bronchitis — like smoking cessation programs, inhalers, or pulmonary rehabilitation — that might offer clearer benefits than what's being studied in this trial, and should I consider those first?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction in 24-hour cough frequency

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

Trial details

NCT IDNCT07108166

SponsorPhilip Morris Products S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Xavier Jaumont, MD

+41582421111 Xavier.Jaumont@pmi.com

View on ClinicalTrials.gov More COPD trials