Translational Studies on Electronic Cigarette-derived Oxidants and Their Long-term Cardiopulmonary Effects
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of exacerbations
研究概览
简要总结
This is a pilot study on the impact of switching from cigarettes to Electronic Cigarettes (EC) on disease-related clinical symptoms and biomarkers of harm in smokers with preexisting Chronic Obstructive Pulmonary Disease (COPD). The researchers hypothesize that the smokers who switch to EC completely or significantly will experience reduced COPD symptoms, risks of exacerbations, and decreased levels of oxidative stress and inflammation.
详细描述
Smokers with COPD have a higher pack-year history and nicotine dependence compared to regular smokers as exemplified by the relatively large proportion of patients diagnosed with COPD that continue to smoke (95%).
This is a translational project which addresses the changing profile of tobacco product use in the United States (US) and the need for data regarding toxicity pathways for new nicotine products such as EC. In particular it focuses on critical scientific and clinically relevant gaps relating to oxidants in EC and their potential long-term cardiopulmonary effects. The study will obtain new information regarding the potential cardiopulmonary toxicity resulting from exposure to EC-derived oxidants that may lead to long-term disease development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate COPD
- •Smokes a popular brand of cigarette
- •Willing to use an e-cigarette to reduce cigarette smoking down to 75% of their daily baseline cigarette use
- •Ability to read, write and understand English
- •Ability to provide informed consent and attend study visits
排除标准
- •History of active, chronic drug abuse or alcohol abuse problems
- •Actively changing smoking behavior
- •Unwilling or unable to provide blood samples
- •Pregnant, planning to become pregnant, or nursing
- •Use of tobacco products other than cigarettes in the past 30 days
- •Recent history (< 6 months) of myocardial infarction (MI)
- •Any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or drug therapy within the past year. Antiarrhythmic drugs include amiodarone, flecainide, IV ibutilide, IV lidocaine, procainamide, propafenone, quinidine, tocainide
- •Hospitalization for heart failure (NY Heart Association III or IV) within the past year
- •Uncontrolled hypertension
- •Known allergy to vegetable glycerin and propylene glycol
- •History of seizures or medications to prevent seizures
研究组 & 干预措施
NJOY e-cigarette
NJOY e-cigarette containing 5% nicotine strength pods
干预措施: NJOY e-cigarette (Drug)
结局指标
主要结局
Number of exacerbations
时间窗: 3 months
Number of COPD exacerbations
Cigarettes per day
时间窗: 3 months
Self reported cigarettes per day
次要结局
- COPD Assessment Test (CAT) scores(3 months)
- Tobacco exposure(3 months)
- Lung function tests (spirometry)(3 months)
- 6-min walk distance (6MWD)(3 months)
研究者
Rebecca Bascom
Professor, Department of Medicine
Penn State Health Milton S Hershey Medical Center