Novel Pulmonary Imaging of Lung Structure and Function in Symptomatic and Asymptomatic E-cigarette Smokers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities.
研究概览
简要总结
This is a longitudinal study of the long-term health impact of e-cigarette smoking on the lungs. Participants will be followed over a period of 5 years, and impacts of e-cigarette smoking on the lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarized xenon-129 gas, pulmonary function tests, exercise capacity, computed tomography images and questionnaires.
详细描述
This is a 5-year longitudinal study of the long-term lung health impact of e-cigarette smoking. Participants with a history of e-cigarette smoking age ≥ 16 years will be recruited from within 2 hours of London, ON through local family and tertiary care physicians, emergency departments and community and social media advertisements. Asymptomatic age and sex-matched participants who have never smoked e- or c-cigarettes will be recruited through community advertisement, media and social media. Participants must satisfy all inclusion and exclusion criteria in order to participate in the study. We will compare lung health of participants at baseline, 12 weeks, 24 weeks and 48 weeks, 3 years, 4 years and 5 years with an asymptomatic control group with no history of e-cigarette or c-cigarette use. The study will involve 6 in-person visits and 1 telephone call for a health update. All measurements will be made with at least 4 hours after the last cigarette and/or vape to provide a way to practically focus on chronic and not acute effects. Pulmonary function and imaging measurements will be made before and after bronchodilator administration.
At Visit 1, informed consent will be obtained before any study related assessments or procedures are performed. Eligibility criteria will be reviewed. Safety assessments including vital signs, pulmonary function testing, hematology, sputum sampling, exercise testing, and respiratory questionnaires will be completed.
Visit 2 will take place 12 weeks after visit 1 and will include vital signs, pre and post bronchodilator pulmonary function testing, pre and post bronchodilator MRI imaging, chest CT scan, exercise testing, and questionnaires.
Visit 3 will take place at 24 weeks and will involve a telephone call to update health information as well as questionnaires.
Visit 4 will take place at 48 weeks and will involve vital signs, pre and post bronchodilator pulmonary function testing, pre and post bronchodilator MRI imaging, hematology, blood chemistry, sputum analysis, exercise testing, and questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent must be directly obtained from legally competent participants before any study-related assessment is performed.
- •Male and female participant age ≥16 years.
- •Participant has recently started vaping, >1 and <5 years weekly use.
- •70 participants will be c-cigarette never users.
- •70 participants will be former or current c-cigarette users.
- •10 asymptomatic age and sex-matched healthy people who have never used e- or c-cigarettes will be controls.
排除标准
- •Participants with contraindications for undergoing an MRI such as participants with MRI-sensitive implants, tattoos with MRI-sensitive dye and severe claustrophobia.
- •Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand written material.
- •Participant unable to perform spirometry or plethysmography maneuvers.
结局指标
主要结局
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities.
时间窗: 12 weeks following enrollment
Measured using computed tomography imaging
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FEV1.
时间窗: 12 weeks following enrollment
Measured using forced expiratory volume in one second (FEV1)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FVC.
时间窗: 12 weeks following enrollment
Measured using forced vital capacity (FVC)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FRC.
时间窗: 12 weeks following enrollment
Measured using functional residual capacity (FRC)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by RV.
时间窗: 12 weeks following enrollment
Measured using residual volume (RV)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FOT.
时间窗: 12 weeks following enrollment
Measured using forced oscillation technique (FOT)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by TLC.
时间窗: 12 weeks following enrollment
Measured using total lung capacity (TLC)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by LCI.
时间窗: 12 weeks following enrollment
Measured using lung clearance index (LCI)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FeNO.
时间窗: 12 weeks following enrollment
Measured using Fractional Exhaled Nitric Oxide (FeNO).
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by exercise capacity
时间窗: 12 weeks following enrollment
Exercise capacity measured by cardio-pulmonary exercise testing (CPET)
次要结局
- Differences in airways between e-cigarette-only smokers and never smokers.(5 years)
- Differences in parenchyma between e-cigarette-only smokers and both e-cigarette and c-cigarette smokers.(5 years)
- Changes in lung function of e-cigarette smokers over time as measured by FVC.(5 years)
- Changes in lung health of e-cigarette smokers over time as measured by SGRQ.(5 years)
- Differences in airways between e-cigarette-only smokers and both e-cigarette and c-cigarette smokers.(5 years)
- Changes in lung function of e-cigarette smokers over time as measured by FEV1.(5 years)
- Changes in lung function of e-cigarette smokers over time as measured by TLC.(5 years)
- Changes in lung function of e-cigarette smokers over time as measured by RV.(5 years)
- Changes in lung health of e-cigarette smokers over time as measured by CAT.(5 years)
- Differences in parenchyma between e-cigarette-only smokers and never smokers.(5 years)
- Changes in airways of e-cigarette smokers over time.(5 years)
- Changes in parenchyma of e-cigarette smokers over time.(5 years)
- Changes in lung function of e-cigarette smokers over time as measured by FRC.(5 years)
- Changes in lung function of e-cigarette smokers over time as measured by exercise capacity.(5 years)
- Changes in lung health of e-cigarette smokers over time as measured by the mMRC dyspnea scale questionnaire.(5 years)
- Changes in lung function of e-cigarette smokers over time as measured by LCI.(5 years)
- Changes in lung function of e-cigarette smokers over time as measured by FeNO.(5 years)
- Changes in lung function of e-cigarette smokers over time as measured by FOT.(5 years)
- Changes in lung health of e-cigarette smokers over time as measured by IPAQ.(5 years)
研究者
Dr. Grace Parraga
PhD, Scientist. Robarts Research Institute
Western University, Canada