Effect of Switching From Cigarette Smoking to THS on Disease Progression in Mild to Moderate COPD… (NCT05569005) | Clinical Trial Compass
TerminatedNot Applicable
Effect of Switching From Cigarette Smoking to THS on Disease Progression in Mild to Moderate COPD Subjects With Chronic Bronchitis Symptoms.
Stopped: The study team decided to terminate the study due to operational infeasibility caused by challenges with recruiting the necessary number of participants.
United States715 participantsStarted 2022-12-16
Plain-language summary
The purpose of this study is to demonstrate the slowing of the disease progression including the improvement of Chronic Obstructive Pulmonary Disease (COPD) symptoms in smoking subjects with mild to moderate COPD and a history of chronic bronchitis symptoms (sputum and cough) who switch to the Tobacco Heating System (THS) as compared to those who continue to smoke cigarettes.
Who can participate
Age range35 Years – 65 Years
SexALL
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Main Inclusion Criteria:
* Subjects have read, understood, and signed the written informed consent form (ICF)
* Diagnosis of COPD GOLD Stage 1 or 2 (FEV1/FVC \<0.70 \& FEV1 ≥60% predicted \[post-BD\])
* Current symptoms of chronic bronchitis (sputum and cough) based on CAT questionnaire scores for CAT1 (cough) item ≥ 3 and CAT2 (sputum) item ≥ 3
* Body mass index (BMI) 17.6-40.0 kg/m2 and body weight \> 50 kg (male) or 40 kg (female).
* Subject has a smoking history of at least 10 years.
* Subject has been smoking ≥ 10 commercially available cigarettes/day on average (no brand restriction) for at least 1 year prior to V1 (based on self-reporting).
* Subject has not used other tobacco and nicotine products apart from cigarettes on a daily basis over the past year prior to V1.
* For subjects not willing to quit smoking only: have been advised to quit smoking, informed of smoking risks and of cessation programs and is still not willing to quit during the study duration.
* Subjects willing to quit smoking only: willing to set a target quit date (TQD) within the next 28 days at V1 as assessed by self-reported questions.
Main Exclusion Criteria:
* Subjects with any (mild, moderate or severe) COPD exacerbation that has not resolved at least four weeks prior to V1
* Subjects with active cancer or history of any cancer
* Subjects with pneumonia or other lower respiratory tract infections that have not resolved at least four weeks prior to V1
* Subjects with other active systemic in…