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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Vaping

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Insel, Bern University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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. 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy controls; 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.
Vaping teenagers; Vaping teenagers will be recruited independently from the BILD study through advertisements and visits to Bernese schools.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of validated vaping status with lung function (spirometry) in healthy teenagers	Assessment of lung function (spirometry)	At baseline
Correlation of validated vaping status with lung function (bodyplethysmography) in healthy teenagers	Assessment of lung function (bodyplethysmography)	At baseline
Correlation of lung function (multiple breath washout) in healthy teenagers	Assessment of lung function (multiple breath washout)	At baseline
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
Correlation of validated vaping status with lung structure (magnetic resonance imaging, MRI) in healthy teenagers.	Assessment of regional lung perfusion and ventilation.	At baseline
Correlation of validated vaping status with measures of oxidative stress in healthy teenagers.	Measurement of oxidative stress metabolites in urine.	At baseline
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
Role of nicotine metabolism on lung health indicators.	Measurement of nicotine metabolites in urine and saliva.	At baseline

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: University of Bern
• Investigators: Principal Investigator: Julian Jakob, MD, Institute of Primary Health Care BIHAM, Bern University; Principal Investigator: Reto Auer, MD, MAS, Institute of Primary Health Care BIHAM, Bern University; Principal Investigator: Philipp Latzin, MD, PhD, Inselspital, Bern University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): February 24, 2023
• Study Completion (Actual): February 24, 2023

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: YTCR3419

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No