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
Qualifiers
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
Treatments tested in this trial
- Cigarette
- THS
Treatment groups
290 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov