NCT07108166进行中（未招募）不适用
A Randomized, Single (Operator)-Blinded, Controlled Clinical Study for Assessing Major Symptoms and Function in Patients With Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis Who Switch From Combustible Cigarettes (CIG) to Tobacco Heating System (THS)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 290
- 试验地点
- 215
- 主要终点
- Reduction in 24-hour cough frequency
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 V
- •Patient has a CIG smoking history ≥ 10 years.
- •Patient has been smoking ≥ 10 commercially available and/or roll-your-own CIG/day on average (no brand restriction) for at least the last year (based on self-reporting). Smoking status will be verified by Urine cotinine test (UCOT) ≥200 ng/mL. Intermittent CIG smoking abstinence, with or without Smoking Cessation Treatment during these attempts, not exceeding 10 days total within the past year will be allowed. Checked at V1 and V
- •Patient has been advised to quit smoking, informed of smoking risks and of cessation programs as per SoC at V2, and is not willing to quit CIG use for the study duration. Checked at V1 and V
- •Patient agrees to be randomized into one of the two study arms. Checked at V
- •Patient with confirmed COPD via spirometry performed at V1 (FEV1/FVC <70%, post-bronchodilator (-BD)) and COPD severity classified by the Global Initiative for Chronic Obstructive Lung Diseases (GOLD) as GOLD 2 or 3 (30%≤ FEV1 < 80% predicted, -BD) with presence of chronic bronchitis (cough and mucus most of the days for > three months a year for the two consecutive years prior to the screening visit). Checked at V
- •Patient has cough frequency of ≥ 10 cough/hour during daytime from objective count sensor applied at V1, used to verify eligibility at V
- •(Daytime is defined as occurring between 07:00:00 and 22:59:59, based on the local time zone of the site where the patient is assessed.)
排除标准
- •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 V
- •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 V
- •Patient with medical condition(s) that would jeopardize his(her) safety in the context of this study (e.g., safety laboratory parameters, abnormal ECG) or with a condition that would jeopardize study results (e.g., gastroesophageal reflux disease (GERD), heart failure, severe chronic lung emphysema, active symptomatic hay fever), as per Investigator's discretion. Checked at V1 and V
- •Patient is legally incompetent, physically, and/or mentally incapable of giving consent (e.g., emergency situation, under guardianship, in a social or sanitary establishment, prisoner or involuntarily incarcerated, unable to read).
- •Patient with a history of asthma.
- •Employee of the investigational site or any other party involved in the study, or their first-degree relatives (parent, child, spouse).
- •Current or former employee of the tobacco or e-cigarette industry or their 1st-degree relatives.
- •Patient with active or history of alcohol and/or drug abuse within the past year.
- •Patient with positive serological tests for human immunodeficiency virus (HIV) 1/2, hepatitis B or C (Hep B/C).
- •Patient with any concomitant issues (e.g., medical, psychiatric, and/or social reason) that, as per Investigator's discretion, would place the study patient at an unacceptable risk for participation in the study.
- •Patient who participated in any trial (for investigational medicine, or other type of intervention) that may have interfered with COPD disease progression and symptoms (including cough and dyspnea) within the last three months as per investigator's discretion.
- •Patient using any systemic (injectable or oral) corticosteroids (acute or chronic treatments) or oxygen therapy in the last 2 months excluding short term use for a COPD exacerbation.
- •Patient currently being treated with angiotensin-converting enzyme (ACE) inhibitors or opioids, or those who have used ACE inhibitors within 4 weeks or opioids within 1 week prior to screening. Checked at V1 and V
- •Patient treated with biologic therapies for COPD (e.g., Dupilumab) in the last 6 months.
- •Female patient is pregnant, breastfeeding or lactating, or anticipating becoming pregnant withing the duration of the study. Checked at V1 and V
- •Female of childbearing potential who is capable of getting pregnant, defined as a female patient who does not agree to use an acceptable method of effective contraception during the entire study, a female patient that is not surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months or postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year). Checked at V1 and V2.
研究组 & 干预措施
THS
Active Comparator
干预措施: THS (Other)
Cigarette
Active Comparator
干预措施: Cigarette (Other)
结局指标
主要结局
Reduction in 24-hour cough frequency
时间窗: Measured from start of product use to end of week 24 (end of the exposure period).
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.
Reduction in 24-hour cough frequency
时间窗: Measured from start of product use to end of week 24 (end of the exposure period).
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.
次要结局
- Changes in lung function (from Baseline in FEV1 post-bronchodilator)(Measured from start of product use to end of week 24 (end of the exposure period).)
- Changes in the 24-hour cough frequency over time(Measured from start of product use to 12 weeks, at the end of weeks 1, 4, and 12.)
- Percentage of patients with a change in 24-hour cough frequency over time(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24)
- Changes in the Cough Quality of Life Questionnaire (CQLQ) on chronic cough(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.)
- Changes in cough severity over time(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.)
- Changes in bronchial hyperresponsiveness (BHR) mannitol test over time(Measured from start of product use to end of week 24 (end of the exposure period).)
- Impact of COPD (cough, sputum, dyspnea, chest tightness) on health status(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.)
- Changes in shortness of breath assessed over time(Measured from start of product use to end of week 24 (end of the exposure period).)
- Changes in functional capacity over time(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 12 and 24.)
- Changes in exposure to carbon monoxide over time(Measured from start of product use to end of week 24 (end of the exposure period).)
- Changes in self-reported tobacco and nicotine containing product consumption(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.)
- Changes in nicotine exposure levels(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.)
- Changes in lung function (from Baseline in FEV1 post-bronchodilator)(Measured from start of product use to end of week 24 (end of the exposure period).)
- Changes in the 24-hour cough frequency over time(Measured from start of product use to 12 weeks, at the end of weeks 1, 4, and 12.)
- Changes in the Cough Quality of Life Questionnaire (CQLQ) on chronic cough(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.)
- Changes in cough severity over time(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.)
- Percentage of patients with a change in 24-hour cough frequency over time(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24)
- Changes in functional capacity over time(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 12 and 24.)
- Changes in bronchial hyperresponsiveness (BHR) mannitol test over time(Measured from start of product use to end of week 24 (end of the exposure period).)
- Impact of COPD (cough, sputum, dyspnea, chest tightness) on health status(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.)
- Changes in exposure to carbon monoxide over time(Measured from start of product use to end of week 24 (end of the exposure period).)
- Changes in shortness of breath assessed over time(Measured from start of product use to end of week 24 (end of the exposure period).)
- Changes in self-reported tobacco and nicotine containing product consumption(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.)
- Changes in nicotine exposure levels(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.)
- Changes in acrylonitrile exposure levels(Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24.)
研究者
研究点 (215)
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