Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS (NCT07108166) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
United States290 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 range40 Years
SexALL
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.
…
What they're measuring
1
Reduction in 24-hour cough frequency
Timeframe: Measured from start of product use to end of week 24 (end of the exposure period).