Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change from Baseline FEV1/FVC Ratio at 2 weeks
研究概览
简要总结
The purpose of this study is to compare the effects of e-cigarettes and continued smoking on pulmonary and cardiac outcomes in a population with established pulmonary disease.
详细描述
E-cigarettes with nicotine can affect important cardiopulmonary outcomes and likely pose less risk than cigarettes, but they are not harmless. Given the existing literature, there is a need for controlled trials of e-cigarette use in populations with cardiopulmonary disease to fill the gaps between these existing examinations. Clarifying how the pulmonary and cardiac effects of e-cigarettes compare to use of conventional cigarettes in those with cardiopulmonary disease beyond single acute exposures will provide important new health information that can help inform policy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Men and women 40 years of age or older
- •Current, every day smoker (5 or more cigarettes per day for one year or longer) confirmed with intake CO of 8ppm or greater
- •Established pulmonary disease (chronic obstructive pulmonary disease [COPD], chronic bronchitis, emphysema, or asthma-COPD overlap syndrome) confirmed by physician diagnosis and/or current prescription of medication for treatment (i.e., LABA, LAMA, +/- ICS, or combination)
- •Lives and plans to remain in the greater Burlington, VT area for the next month
- •No intention to quit smoking within the next month
- •Speaks English
排除标准
- •Patients who are medically unstable (unstable symptoms, changes in medications or hospitalizations within last 3 months)
- •Inability to conduct in-home measurements.
研究组 & 干预措施
Combustible Cigarette
Participants in this arm will smoke their usual brand of combustible cigarettes for two weeks.
E-Cigarette
Participants in this arm will smoke electronic cigarettes for two weeks. E-cigarettes (either JUUL or Vuse Alto) and pods (JUUL: Virginia tobacco flavor at 3% or 5% nicotine concentration; Vuse Alto: golden tobacco flavor at 1.8%, 2.4%, or 5% nicotine concentration) will be provided.
干预措施: E-Cigarette (Other)
E-Cigarette
Participants in this arm will smoke electronic cigarettes for two weeks. E-cigarettes (either JUUL or Vuse Alto) and pods (JUUL: Virginia tobacco flavor at 3% or 5% nicotine concentration; Vuse Alto: golden tobacco flavor at 1.8%, 2.4%, or 5% nicotine concentration) will be provided.
干预措施: Financial Incentives (Behavioral)
结局指标
主要结局
Change from Baseline FEV1/FVC Ratio at 2 weeks
时间窗: Assessment completed 2 weeks after intake assessment
Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry
Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19)
时间窗: Intake assessment
Airway impedence in the lungs as measured by oscillometry
Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 4 weeks
时间窗: Assessment completed 4 weeks after intake assessment
Airway impedence in the lungs as measured by oscillometry
Baseline FEV1/FVC Ratio
时间窗: Intake assessment
Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry
Change from Baseline FEV1/FVC Ratio at 4 weeks
时间窗: Assessment completed 4 weeks after intake assessment
Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry
Baseline Lung Reactance at 5Hz (X5)
时间窗: Intake assessment
Measurement of the ability of the lung to store energy, as measured by oscillometry
Baseline Oxygen Saturation (SpO2)
时间窗: Intake assessment
Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
Change from Baseline Oxygen Saturation (SpO2) at 4 weeks
时间窗: Assessment completed 4 weeks after intake assessment
Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
Change from Baseline FEV1/FVC Ratio each day
时间窗: Daily through study completion, an average of 4 weeks
Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry
Change from Baseline Oxygen Saturation (SpO2) at 2 weeks
时间窗: Assessment completed 2 weeks after intake assessment
Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
Baseline Fractional Exhaled Nitric Oxide (FeNO)
时间窗: Intake assessment
Amount of nitric oxide in the breath
Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks
时间窗: Assessment completed 2 weeks after intake assessment
Amount of nitric oxide in the breath
Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 2 weeks
时间窗: Assessment completed 2 weeks after intake assessment
Airway impedence in the lungs as measured by oscillometry
Change from Baseline Oxygen Saturation (SpO2) each day
时间窗: Daily through study completion, an average of 4 weeks
Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
Baseline St. George's Respiratory Questionnaire for COPD Patients Score
时间窗: Intake assessment
Score measuring the impact of COPD on overall health, daily life, and perceived well-being; scale of 0-100; higher scores indicate more limitations on overall health
Change from Baseline Lung Reactance at 5Hz (X5) at 2 weeks
时间窗: Assessment completed 2 weeks after intake assessment
Measurement of the ability of the lung to store energy, as measured by oscillometry
Change from Baseline Lung Reactance at 5Hz (X5) at 4 weeks
时间窗: Assessment completed 4 weeks after intake assessment
Measurement of the ability of the lung to store energy, as measured by oscillometry
Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 4 weeks
时间窗: Assessment completed 4 weeks after intake assessment
Amount of nitric oxide in the breath
Baseline COPD Assessment Test Score
时间窗: Intake assessment
Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome
Change from Baseline COPD Assessment Test Score at 2 weeks
时间窗: Assessment completed 2 weeks after intake assessment
Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome
Change from Baseline COPD Assessment Test Score at 4 weeks
时间窗: Assessment completed 4 weeks after intake assessment
Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome
Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 2 weeks
时间窗: Assessment completed 2 weeks after intake assessment
Score measuring the impact of COPD on overall health, daily life, and perceived well-being; scale of 0-100; higher scores indicate more limitations on overall health
Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 4 weeks
时间窗: Assessment completed 4 weeks after intake assessment
Score measuring the impact of COPD on overall health, daily life, and perceived well-being; scale of 0-100; higher scores indicate more limitations on overall health
次要结局
- Baseline Blood Pressure(Intake assessment)
- Baseline Heart Rate(Intake assessment)
- Change From Baseline Heart Rate at 4 weeks(Assessment completed 4 weeks after intake assessment)
- Change from Baseline Heart Rate each day(Daily through study completion, an average of 4 weeks)
- Change from Baseline Blood Pressure at 4 weeks(Assessment completed 4 weeks after intake assessment)
- Change From Baseline Heart Rate at 2 weeks(Assessment completed 2 weeks after intake assessment)
- Change from Baseline Blood Pressure each day(Daily through study completion, an average of 4 weeks)
- Change from Baseline Blood Pressure at 2 weeks(Assessment completed 2 weeks after intake assessment)
研究者
Diann Gaalema
Associate Professor, Department of Psychiatry
University of Vermont