ClinicaliQ Trial Snapshot
- Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS — Recruiting • Non-phase study • Respiratory / COPD / Asthma • NCT07108166.
- What is being tested: A randomized controlled trial evaluating whether patients with COPD and chronic bronchitis who switch from cigarette smoking to tobacco heating system (THS) experience direct clinical benefits, including improvements in respiratory symptoms (cough frequency, dyspnoea) and objective lung function….
- Patient eligibility overview: The study recruits adults with established COPD and chronic bronchitis who are current smokers, randomizing them to either switch to THS or continue smoking, with follow-up assessment of clinical outcomes over the study period.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * 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 …
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.