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.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 715
- 试验地点
- 170
- 主要终点
- Disease Progression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main 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.
排除标准
- •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
- •Positive serology test (HIV 1/2, hepatitis B or C).
- •Inability to cooperate with the study procedures
- •Previous participation in this study, or participation in an investigational study (drug or medical device) within 4 weeks before V1 (participation in observational studies/registries allowed)
- •Close affiliation with the investigational site: a close relative of the investigator, a person dependent on the investigational site (e.g., employee or student of the investigational site)
- •Subject is a current or former employee of the tobacco industry or their first-degree relatives (parent, child, spouse)
- •Subjects have re-initiated smoking in the six months prior to V1
- •Subjects have used in the past 3 months, or are currently daily using THS
- •Any oral/injectable corticosteroids (acute or chronic treatments) or oxygen therapy in the last 2 months excluding short term use for a COPD exacerbation
- •Female subject is pregnant or breastfeeding, (a urine pregnancy test will be performed at V1 and V2)
- •For women of childbearing potential, female subject who does not agree to using an acceptable method of effective contraception during the entire study.
研究组 & 干预措施
THS
Subjects who are not willing to quit smoking.
干预措施: THS use (Other)
Cigarette
Subjects who are not willing to quit smoking.
干预措施: Cigarette (Other)
Smoking Abstinence
Subjects who are willing to quit smoking.
干预措施: Smoking Abstinence (Other)
结局指标
主要结局
Disease Progression
时间窗: At month 36
Disease progression will be assessed by measuring Forced Expiratory Volume in 1 second (FEV1), post-bronchodilator
COPD symptoms
时间窗: At month 12
COPD symptoms will be assessed from the total score of the COPD Assessment Test (CAT).
次要结局
未报告次要终点