jRCT1030230080暂停不适用
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
- 暂停
- 入组人数
- 1,895
- 主要终点
- COPD Assessment Test (CAT) total score
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 35age old over 至 65age old under（—）
- 性别
- All
入选标准
- •Subjects have read, understood, and signed the written informed consent form (ICF)
- •Diagnosis of COPD GOLD Stage 1 or 2 (FEV1/FVC <0.7 and FEV1 >=60% predicted [post-BD])
- •History of chronic bronchitis symptoms (sputum and cough) over the previous 12 months assessed by CAT1 and CAT2 scores >= 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 other relevant pulmonary diseases than COPD. No new examination is required if the subject can present at V1, a Chest X-Ray (CXR) not older than 6 months with anterior-posterior and left lateral views
- •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: tuberculosis, lung cancer, bronchiectasis, sarcoidosis, asthma, pulmonary hypertension, interstitial lung diseases (e.g., idiopathic pulmonary fibrosis [IPF]), or other active pulmonary diseases during the screening period (V1 to V2)
- •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 (other than tetrahydrocannabinol [THC]).
- •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 or injectable corticosteroids (acute or chronic treatments) in the 2 months preceding V1, 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.
结局指标
主要结局
COPD Assessment Test (CAT) total score
时间窗: Month 12
COPD Assessment Test (CAT) total score at Month 12 for the interim analysis
Forced Expiratory Volume in 1 second (FEV1), post-bronchodilator (-BD)
时间窗: Month 36
Forced Expiratory Volume in 1 second (FEV1), post-bronchodilator (-BD) at Month 36
次要结局
未报告次要终点
研究者
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