Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
A Randomized, Single (Operator)-Blinded, Controlled Clinical Study for Assessing Major Symptoms and Function in Patients With Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis Who Switch From Combustible Cigarettes (CIG) to Tobacco Heating System (THS)
About This Trial
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 May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Cigarette
COPD patients will continue to smoke their cigarettes ad libitum, with no brand restrictions.
THS
COPD patients will switch from cigarette smoking to ad libitum THS use, with no flavor variant restrictions.