Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorPhilip Morris Products S.A.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patient who self-report concomitant daily use of inhaled cannabis or any type of nicotine containing products other than CIG within the last year.
Patient with COPD (moderate or severe) exacerbation that has not resolved according to the GOLD standard (e.g., requirement of additional therapy) or investigator's discretion. Checked at V1 and V2.
Patient with currently active cancer or history of any cancer within the last 5 years prior to V1, except for those with basal cell carcinoma of the skin.
Patient with acute worsening symptoms of chronic bronchitis or other active respiratory or systemic infections that have not resolved. Checked at V1 and V2.
Trial design
Design model
Parallel
Treatments tested in this trial
Cigarette
Other interventionCOPD patients will continue to smoke their cigarettes ad libitum, with no brand restrictions.
THS
Other interventionCOPD patients will switch from cigarette smoking to ad libitum THS use, with no flavor variant restrictions.
Treatment groups
290 Participants
are divided into 2 treatment groupsGroup A: CigaretteActive comparator 1 intervention
Group B: THSActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).Secondary outcomes
1
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).2
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 12.3
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 244
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.
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.Sponsors and contacts
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Source ClinicalTrials.gov