Effects of Electronic Cigarettes on Smokers With Mild to Moderate Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in cigarettes per day
研究概览
简要总结
This study evaluates the effects of electronic cigarette use on cigarette smoking and markers of tobacco use, as well as respiratory symptoms and function in smokers with mild to moderate chronic obstructive pulmonary disease (COPD). All participants will receive a 12 week supply of electronic cigarettes to use instead of their regular conventional cigarettes.
详细描述
Electronic cigarettes are devices that heat a solution containing nicotine to form an aerosol that is then inhaled by the user. Electronic cigarettes are used by many smokers, including smokers with chronic health conditions such as COPD. Given that e-cigarettes are still relatively new, their effects on health are not well defined.
It is important to understand how electronic cigarettes affects symptoms and lung function in smokers with COPD to determine the short-term safety of these products. To do this, an initial step involves observing the extent to which smokers substitute their conventional cigarette use with electronic cigarette use and change their exposure to tobacco use biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 10 pack year smoking history
- •Daily use of at least 5 cigarettes
- •No plan to quit cigarettes in the next 30 days
- •Willing to use e-cigarettes
- •Diagnosis of COPD (FEV1/forced vital capacity [FVC] <0.70) with mild (FEV1 >80% predicted) or moderate (FEV1 <80% but >50% predicted) airflow limitation (post-bronchodilator); confirmed by spirometry
- •English-speaking
排除标准
- •Past 30-day use of nicotine-containing products (cigars, cigarillos, hookah, electronic cigarettes, smokeless tobacco, nicotine replacement therapy)
- •Past 30 day use of inhaled drugs (marijuana, crack)
- •Pregnant or breastfeeding
- •Planning to become pregnant within the next 3 months or unable to agree to use appropriate contraception during study
- •Pulmonary disease other than COPD or asthma
- •Ever requiring mechanical ventilation
- •2 or more hospitalizations for COPD in the past 12 months
- •Cardiac hospitalization in the past 6 months
- •Active chest pain or palpitations
- •Uncontrolled hypertension (blood pressure >160/100)
- •Oxygen therapy
- •Inability or contraindication to perform spirometry (e.g. recent eye, thoracic, or abdominal surgery)
- •Known allergy to propylene glycol or vegetable glycerin
- •Unable to consent or complete assessments
结局指标
主要结局
Change in cigarettes per day
时间窗: baseline and 12 weeks
Change in self-reported cigarettes per day from Week 0 to Week 12
次要结局
- St. George's Respiratory Questionnaire(baseline and 12 weeks)
- Change in urine anabasine(baseline and 12 weeks)
- Change in exhaled carbon monoxide(baseline and 12 weeks)
- Change in urine cotinine(baseline and 12 weeks)
- Transition Dyspnea Index(baseline and 12 weeks)
- Change in pulmonary function(baseline and 12 weeks)
研究者
Sara Kalkhoran
Assistant Professor of Medicine
Massachusetts General Hospital