A 3-year, 3-group, Preference, Multi-center Study to Demonstrate the Slowing of Disease Progression When Switching From Cigarette Smoking to the Tobacco Heating System (THS) in Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) Subjects With a History of Chronic Bronchitis Symptoms.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- Philip Morris Products S.A.
- Enrollment
- 1895
- Locations
- 170
- Primary Endpoint
- Disease Progression
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
This study will be a multiregional (Europe, U.S., and Asia) multi-center, open-label study with 3-group, parallel preference design (Cigarette, THS use, and Smoking Abstinence). Subjects will self-select their group allocation according to their preference. Subjects who would like to quit cigarettes or THS during the study will be encouraged to do so and will be referred to appropriate services. The study will be declared successful if a slowing of the disease progression is demonstrated with the primary objective endpoint of forced expiratory volume in the first second (FEV1) post-bronchodilator at Month 36 or if an improvement of COPD symptoms (COPD Assessment Test total score at interim analysis at Month 12) is demonstrated.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects have read, understood, and signed the written informed consent form (ICF)
- •Diagnosis of COPD GOLD Stage 1 or 2 (FEV1/FVC \<0.70 \& FEV1 ≥60% predicted \[post-BD\])
- •Current symptoms of chronic bronchitis (sputum and cough) based on CAT questionnaire scores for CAT1 (cough) item ≥ 3 and CAT2 (sputum) item ≥ 3
- •Body mass index (BMI) 17.6-40.0 kg/m2 and body weight \> 50 kg (male) or 40 kg (female).
- •Subject has a smoking history of at least 10 years.
- •Subject has been smoking ≥ 10 commercially available cigarettes/day on average (no brand restriction) for at least 1 year prior to V1 (based on self-reporting).
- •Subject has not used other tobacco and nicotine products apart from cigarettes on a daily basis over the past year prior to V
- •For subjects not willing to quit smoking only: have been advised to quit smoking, informed of smoking risks and of cessation programs and is still not willing to quit during the study duration.
- •Subjects willing to quit smoking only: willing to set a target quit date (TQD) within the next 28 days at V1 as assessed by self-reported questions.
Exclusion Criteria
- •Subjects with any (mild, moderate or severe) COPD exacerbation that has not resolved at least four weeks prior to V1
- •Subjects with active cancer or history of any cancer
- •Subjects with pneumonia or other lower respiratory tract infections that have not resolved at least four weeks prior to V1
- •Subjects with other active systemic infections that have not resolved at least 4 weeks prior to V1
- •Subjects with other active respiratory disorders such as, but not limited to, tuberculosis, bronchiectasis, sarcoidosis, asthma2, pulmonary hypertension, interstitial lung diseases (e.g., idiopathic pulmonary fibrosis \[IPF\]). No new examination is required if the subject can present at V1, at a minimum, a Chest XRay (CXR) (or Computed Tomography (CT) of the chest, if available) not older than 6 months with anterior-posterior and left lateral views
- •The subject is confirmed or suspected with active SARS-CoV-2 infection (as per site and per country recommendation)
- •Clinically significant ECG alterations that will not allow subject to participate in the study, per Investigator's discretion
- •Any concomitant disease that in the opinion of the investigator would interfere with the study procedures
- •Subjects with diagnosed alpha-1 antitrypsin deficiency (AATD)
- •History of alcohol and/or drug abuse which as per judgment of the Investigator would jeopardize either the participation in an investigational study or safety of the subject
Outcomes
Primary Outcomes
Disease Progression
Time Frame: At month 36
Disease progression will be assessed by measuring Forced Expiratory Volume in 1 second (FEV1), post-bronchodilator
COPD symptoms
Time Frame: At month 12
COPD symptoms will be assessed from the total score of the COPD Assessment Test (CAT).