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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
290
Reduction in 24-hour cough frequency
To demonstrate a change in 24-hour cough frequency in COPD patients with chronic bronchitis switching from cigarette (CIG) to THS compared to those who continue to smoke CIG.
Time frame: Measured from start of product use to end of week 24 (end of the exposure period).
Changes in lung function (from Baseline in FEV1 post-bronchodilator)
To describe changes from Baseline in FEV1 post-bronchodilator in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG.
Time frame: Measured from start of product use to end of week 24 (end of the exposure period).
Changes in the 24-hour cough frequency over time
To describe changes in the 24-hour cough frequency over time in in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG.
Time frame: Measured from start of product use to 12 weeks, at the end of weeks 1, 4, and 12.
Percentage of patients with a change in 24-hour cough frequency over time
To describe the percentage of patients with a change in 24-hour cough frequency over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG.
Time frame: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24
Changes in the Cough Quality of Life Questionnaire (CQLQ) on chronic cough
To describe changes in the Cough Quality of Life Questionnaire (CQLQ) on chronic cough in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG. It consists of 28 items to which the patient responds on a 4-point Likert scale, ranging from 1=strongly disagree, to 4=strongly agree. The total score is the sum of all individual items. Lower scores indicate a better outcome.
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Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
NOT_YET_RECRUITINGFlorida International Medical Research
Coral Gables, Florida, United States
RECRUITINGAlfa Medical Research
Davie, Florida, United States
RECRUITINGOmega Research Debary, LLC
DeBary, Florida, United States
NOT_YET_RECRUITINGD&H Doral Research Center
Doral, Florida, United States
RECRUITINGFelicidad Med Research
Hialeah, Florida, United States
RECRUITINGThe Medici Medical Research, LLC
Hollywood, Florida, United States
NOT_YET_RECRUITINGD&H Pompano Research Center
Margate, Florida, United States
RECRUITINGMed-Care Research Corp
Miami, Florida, United States
RECRUITINGEMDA Clincal Research
Miami, Florida, United States
RECRUITING...and 101 more locations
Time frame: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.
Changes in cough severity over time
To describe changes in cough severity over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG.
Time frame: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.
Changes in bronchial hyperresponsiveness (BHR) mannitol test over time
To describe changes in bronchial hyperresponsiveness (BHR) mannitol test over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG, at sites with full testing capabilities for BHR testing.
Time frame: Measured from start of product use to end of week 24 (end of the exposure period).
Impact of COPD (cough, sputum, dyspnea, chest tightness) on health status
To assess the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status in COPD by the COPD Assessment Test (CAT) over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG. The CAT questionnaire consists of eight items, each answered on a semantic six-point differential scale from 0 to 5. The CAT score is calculated as the sum of the responses. Scores range from 0 to 40 with higher scores representing worse health outcomes.
Time frame: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.
Changes in shortness of breath assessed over time
To describe changes in shortness of breath assessed over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG.
Time frame: Measured from start of product use to end of week 24 (end of the exposure period).
Changes in functional capacity over time
To describe changes in functional capacity over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG.
Time frame: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 12 and 24.
Changes in exposure to carbon monoxide over time
Change from Baseline in carbon monoxide (CO) exposure levels measured from venous blood carboxyhemoglobin (COHb) at the end of weeks 1, 4, 12, and 24.
Time frame: Measured from start of product use to end of week 24 (end of the exposure period).
Changes in self-reported tobacco and nicotine containing product consumption
Changes from Baseline in self-reported tobacco and nicotine containing product consumption and change in self-reported CIG and overall tobacco consumption evaluated with the ABOUT Tobacco exposure Tool (ABOUT-TeT). This instrument is a questionnaire to record self-reported consumption of tobacco and nicotine containing products. Patients will be asked to self-report the number of CIG, THS Induction Sticks, and other tobacco and nicotine containing products used on average per day over the last week. Patients will complete the questionnaire every seven days, from week 1 to week 24.
Time frame: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.
Changes in nicotine exposure levels
Change from Baseline in nicotine exposure levels in spot urine adjusted to creatinine (Nicotine equivalents \[NEQ\]).
Time frame: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.
Changes in acrylonitrile exposure levels
Change from Baseline in acrylonitrile exposure levels in 2-Cyanoethyl Mercapturic Acid N-Acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA) measured in urine and expressed as concentration adjusted to creatinine.
Time frame: Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.