The e-BILD Study: Effects of E-cigarettes on Lung Health in Teenagers.

Lung Diseases Clinical Trial

— e-BILD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05105555
• Other study ID #: YTCR3419
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: February 24, 2023

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 24, 2023
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Lung Diseases
• Vaping

Locations

Country	Name	City	State
Switzerland	Insel, Bern University Hospital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of the respiratory symptom coughing with vaping status (validated by exposure markers)	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	At baseline
Primary	Correlation of the respiratory symptom wheezing with vaping status (validated by exposure markers)	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	At baseline
Secondary	Correlation of validated vaping status with lung function (spirometry) in healthy teenagers	Assessment of lung function (spirometry)	At baseline
Secondary	Correlation of validated vaping status with lung function (bodyplethysmography) in healthy teenagers	Assessment of lung function (bodyplethysmography)	At baseline
Secondary	Correlation of lung function (multiple breath washout) in healthy teenagers	Assessment of lung function (multiple breath washout)	At baseline
Secondary	Correlation of validated vaping status with airway inflammation (exhaled nitric oxide) in healthy teenagers.	Assessment of levels of exhaled nitric oxide (eNO) measured by chemoluminescence analyzers in combination with ultrasound-based flow measurement.	At baseline
Secondary	Correlation of validated vaping status with lung structure (magnetic resonance imaging, MRI) in healthy teenagers.	Assessment of regional lung perfusion and ventilation.	At baseline
Secondary	Correlation of validated vaping status with measures of oxidative stress in healthy teenagers.	Measurement of oxidative stress metabolites in urine.	At baseline
Secondary	Correlation of validated vaping status with ex vivo immune response of nasal epithelial cells in healthy teenagers.	Assessment of nasal epithelial cell immune response collected by nasal brushing.	At baseline
Secondary	Role of nicotine metabolism on lung health indicators.	Measurement of nicotine metabolites in urine and saliva.	At baseline