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临床试验/NCT05105555
NCT05105555已完成不适用

The e-BILD Study: Effects of Electric Nicotine Delivery Systems (ENDS) on Pulmonary Health in Teenagers.

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Correlation of the respiratory symptom coughing with vaping status (validated by exposure markers)

研究概览

简要总结

Electronic nicotine delivery systems (ENDS/e-cigarettes/vaping) are increasingly popular among teenagers around the world. The safety and potential adverse effects of ENDS in this population are largely unknown. While the aerosol, that users inhale, appears safe under laboratory conditions, there are still open questions, which have not yet been assessed. These cover (a) differences in exposure to chemicals (such as metabolites of Volatile Organic Compounds (VOCs) and metabolites of Polycyclic Aromatic Hydrocarbons (PAHs)) between healthy teenagers using ENDS and healthy teenagers not vaping, (b) effects of exposure to such chemicals on the body (measured by lung health indicators: airway symptoms such as coughing; lung function and lung structure tests; immune response of airway cells exposed to vapor; markers of oxidative stress), and (c) the role of nicotine metabolism. It is unknown which lung health indicator/s is/are most relevant to assess the effect of ENDS on lung health in teenagers.

The primary hypothesis of this study is that there will be differences in exposure to chemicals, resulting in more or more severe airway symptoms in vaping teenagers compared to their non-vaping peers. While there might not yet exist any differences regarding lung function or structure, we expect already visible effects of vaping on the local immune response of primary cells isolated from airways in vaping teenagers as compared to non-vaping peers.

In this study, participants of the Bern Basel Infant Lung Development (BILD) cohort, a birth cohort of healthy term-born infants and their follow-up, will serve as healthy, non-vaping controls.1 Vaping teenagers will be recruited independently from the BILD study through advertisements and visits to Bernese schools. Both populations combined represent the study population of the e-BILD study. All e-BILD study participants will undergo the same investigations. While these are currently planned for once in a time (so-called cross-sectional design) to compare results from non-vaping BILD study participants to otherwise healthy but vaping teenagers, repeated measures might follow, depending on the findings of the first phase.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
15 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Informed consent as documented by signature
  • BILD study participants: see inclusion criteria of BILD study (NCT04286464), non-vaping
  • e-BILD: healthy, term-born, vaping at least weekly (might include healthy, vaping participants from BILD)

排除标准

  • None, except for general exclusion criteria of BILD study (NCT04286464)

结局指标

主要结局

Correlation of the respiratory symptom coughing with vaping status (validated by exposure markers)

时间窗: At baseline

Questions on frequency and intensity of coughing in past 12 months. Assessment of exposure markers (urinary concentrations of metabolites of VOCs (volatile organic compounds), urinary concentrations of metabolites of PAHs (Polycyclic aromatic hydrocarbons), urinary concentrations of urinary TSNA (Tobacco Specific Nitrosamines), urinary concentration of nicotine metabolites) to discriminate between vapers and non-vapers \[Time Frame: at baseline\] Urine sampling

Correlation of the respiratory symptom wheezing with vaping status (validated by exposure markers)

时间窗: At baseline

Questions on frequency and intensity of wheezing in past 12 months. Assessment of exposure markers (urinary concentrations of metabolites of VOCs (volatile organic compounds), urinary concentrations of metabolites of PAHs (Polycyclic aromatic hydrocarbons), urinary concentrations of urinary TSNA (Tobacco Specific Nitrosamines), urinary concentration of nicotine metabolites) to discriminate between vapers and non-vapers \[Time Frame: at baseline\] Urine sampling

次要结局

  • Correlation of validated vaping status with ex vivo immune response of nasal epithelial cells in healthy teenagers.(At baseline)
  • Correlation of validated vaping status with airway inflammation (exhaled nitric oxide) in healthy teenagers.(At baseline)
  • Correlation of validated vaping status with lung function (spirometry) in healthy teenagers(At baseline)
  • Correlation of lung function (multiple breath washout) in healthy teenagers(At baseline)
  • Correlation of validated vaping status with lung structure (magnetic resonance imaging, MRI) in healthy teenagers.(At baseline)
  • Correlation of validated vaping status with measures of oxidative stress in healthy teenagers.(At baseline)
  • Correlation of validated vaping status with lung function (bodyplethysmography) in healthy teenagers(At baseline)
  • Role of nicotine metabolism on lung health indicators.(At baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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