Effect of Switching From Cigarette Smoking to THS on Disease Progression in Mild to Moderate COPD Subjects With Chronic Bronchitis Symptoms.
NCT05569005 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 715
Last updated 2024-09-26
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.
Conditions
- COPD
- Smoking
- Tobacco Use
Interventions
- OTHER
-
THS use
Subjects who are not willing to quit smoking during the study duration will switch from cigarettes to using THS
- OTHER
-
Cigarette
Subjects who are not willing to quit smoking during the study duration will continue smoking their own preferred brand of commercially available cigarettes.
- OTHER
-
Smoking Abstinence
Subjects who are willing to quit smoking may be prescribed an NRT to support them in remaining abstinent from use of any tobacco and nicotine containing products during the study. (Behavioral support will be provided to subjects to aid with abstinence.)
Sponsors & Collaborators
-
Philip Morris Products S.A.
lead INDUSTRY
Principal Investigators
-
Christelle Haziza, PhD · Philip Morris Products S.A.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-16
- Primary Completion
- 2024-09-13
- Completion
- 2024-09-13
Countries
- United States
- Bulgaria
- Czechia
- Germany
- Japan
- Romania
- Slovakia
- United Kingdom
Study Locations
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