Electronic Nicotine Delivery Devices and Potential Progression to Acute Lung Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Difference in pulmonary function comparing vaping and non vaping participants (1)
研究概览
简要总结
This is an observational - data and specimen collection study. There have been increasing reports of vaping-induced lung injury, including severe lung injury and rare cases of death. The mechanism by which vaping contributes to lung injury in susceptible persons is unknown, as is impact on chronic lung disease. The investigators aim to identify individuals with chronic electronic nicotine delivery device (ENDD) exposure and matched controls within our ongoing cohort of HIV+ and HIV-uninfected individuals, collect PFT data, bank respiratory and stool samples and collect clinical data for studies of clinical risk, inflammation, biomarkers, and the microbiome in the identification and modification of risk of progression to lung injury or chronic pulmonary disease.
详细描述
Participants will be consented and undergo collection of data and specimens as listed below.
- Vaping use will be determined by history.
- No administration, dispensing or use of any vape product will take place as part of the study.
Experimental procedures:
Respiratory questionnaires and data review:
Detailed data regarding smoking history, illicit drug use, ART and other medications, and medical history are obtained using standardized questionnaires and medical record review. The Modified Medical Research Council Dyspnea scale (MMRC), the St. George's Questionnaire(SGQT), Pulmonary questionnaire (PQ) and a Vaping questionnaire will be administered. These are paper and pencil questionnaires that inquire about respiratory symptoms, quality of life, and other lung related issues. Laboratory data including CD4 cell counts and HIV viral levels are obtained from the medical record.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women age 18 to 80
- •Participant in a previous HLRC study, or a participant in the HIV PACT clinic or referred by a PACCM physician
- •At least weekly vape use over the past 3 months
- •OR No previous history of vape use and no current history of smoking tobacco for controls
- •negative pregnancy test (for women of child barring capabilities)
排除标准
- •pregnancy or breast-feeding (urine pregnancy done on all females of child bearing potential- - - males and females who are at least 1 year post menopausal or surgically sterile will not be tested)
- •Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.).
- •Increasing respiratory symptoms or febrile (temperature >100.40F [380C]) within 4 weeks of study entry.
- •Acute cardiopulmonary issue in the past 4 months.
- •Uncontrolled hypertension at screening visit (systolic > 180 mm Hg or diastolic > 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled.
- •Active cancer requiring systemic chemotherapy or radiation.
- •Active infection of lungs, brain, or abdomen.
- •Intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator.
- •subjects with an upper or lower respiratory tract infection
- •Persons who have tested positive for Covid 19 in the past 4 weeks.
结局指标
主要结局
Difference in pulmonary function comparing vaping and non vaping participants (1)
时间窗: Before bronchodilation
The routine lung function endpoints of FVC, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.
Difference in pulmonary function comparing vaping and non vaping participants (3)
时间窗: Before bronchodilation
The routine lung function endpoints of FEV1/FVC, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.
Difference in pulmonary function comparing vaping and non vaping participants (PB3)
时间窗: within 10 minutes after bronchodilation
The routine lung function endpoints of FEV1/FVC, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.
Difference in diffusion capacity comparing vaping and non vaping participants
时间窗: within 15 minutes after bronchodilation
The routine lung function diffusion lung capacity for carbon monoxide (DLCO) will be measured.
Difference in pulmonary function comparing vaping and non vaping participants (2)
时间窗: Before bronchodilation
The routine lung function endpoints of FEV1, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.
Difference in pulmonary function comparing vaping and non vaping participants (4)
时间窗: Before bronchodilation
The routine lung function endpoints of FEF25-75%, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.
Difference in pulmonary function comparing vaping and non vaping participants (PB1)
时间窗: within 10 minutes after bronchodilation
The routine lung function endpoints of FVC, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.
Difference in pulmonary function comparing vaping and non vaping participants (PB2)
时间窗: within 10 minutes after bronchodilation
The routine lung function endpoints of FEV1 will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.
Difference in pulmonary function comparing vaping and non vaping participants (PB4)
时间窗: within 10 minutes after bronchodilation
The routine lung function endpoints of FEF25-75%, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.
次要结局
- Measurement of the inflammone in vaping and non vaping persons(collection at one visit - will complete analysis in 2 years.)
- Change in inflammation(collected at one visit -will complete analysis in 2 years.)
- comparison of microbial communities in stool(one stool collection at the subjects convenience - will complete analysis in 2 years.)
研究者
Alison Morris
Professor
University of Pittsburgh