Clinical trial NCT05105555: The e-BILD Study: Effects of E-cigarettes on Lung Health in Teenagers.
Official title: The e-BILD Study: Effects of Electric Nicotine Delivery Systems (ENDS) on Pulmonary Health in Teenagers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaping
Lung Diseases
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2021-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Correlation of the respiratory symptom coughing with vaping status (validated by exposure markers)
timeFrame: At baseline
measure: Correlation of the respiratory symptom wheezing with vaping status (validated by exposure markers)
timeFrame: At baseline
Secondary outcomes:
measure: Correlation of validated vaping status with lung function (spirometry) in healthy teenagers
timeFrame: At baseline
measure: Correlation of validated vaping status with lung function (bodyplethysmography) in healthy teenagers
timeFrame: At baseline
measure: Correlation of lung function (multiple breath washout) in healthy teenagers
timeFrame: At baseline
measure: Correlation of validated vaping status with airway inflammation (exhaled nitric oxide) in healthy teenagers.
timeFrame: At baseline
measure: Correlation of validated vaping status with lung structure (magnetic resonance imaging, MRI) in healthy teenagers.
timeFrame: At baseline
measure: Correlation of validated vaping status with measures of oxidative stress in healthy teenagers.
timeFrame: At baseline
measure: Correlation of validated vaping status with ex vivo immune response of nasal epithelial cells in healthy teenagers.
timeFrame: At baseline
measure: Role of nicotine metabolism on lung health indicators.
timeFrame: At baseline
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Insel, Bern University Hospital
Study officials:
affiliation: Institute of Primary Health Care BIHAM, Bern University
name: Julian Jakob, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Primary Health Care BIHAM, Bern University
name: Reto Auer, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: Inselspital, Bern University Hospital
name: Philipp Latzin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: