Vapinge-BILDNCT05105555
The e-BILD Study: Effects of E-cigarettes on Lung Health in Teenagers.
An observational study of Vaping and Lung Diseases, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaping, Lung Diseases
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2022to 24 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- None, except for general exclusion criteria of BILD study (NCT04286464)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vaping, Lung Diseases
- Medical subject headings
- Vaping, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At baseline
Secondary outcomes (8)
Correlation of validated vaping status with lung function (spirometry) in healthy teenagers
Assessment of lung function (spirometry)
Measured: At baseline
Correlation of validated vaping status with lung function (bodyplethysmography) in healthy teenagers
Assessment of lung function (bodyplethysmography)
Measured: At baseline
Correlation of lung function (multiple breath washout) in healthy teenagers
Assessment of lung function (multiple breath washout)
Measured: 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.
Measured: At baseline
Correlation of validated vaping status with lung structure (magnetic resonance imaging, MRI) in healthy teenagers.
Assessment of regional lung perfusion and ventilation.
Measured: At baseline
Correlation of validated vaping status with measures of oxidative stress in healthy teenagers.
Measurement of oxidative stress metabolites in urine.
Measured: 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.
Measured: At baseline
Role of nicotine metabolism on lung health indicators.
Measurement of nicotine metabolites in urine and saliva.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Feb 2022
- Primary completion24 Feb 2023
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VapingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Julian Jakob, MD, Principal investigator, Institute of Primary Health Care BIHAM, Bern UniversityReto Auer, MD, MAS, Principal investigator, Institute of Primary Health Care BIHAM, Bern UniversityPhilipp Latzin, MD, PhD, Principal investigator, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105555
- Sponsor's protocol ID
- YTCR3419
- Acronym
- e-BILD
- Status last verified
- Mar 2023
- First submitted
- 20 Sep 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The e-BILD Study: Effects of Electric Nicotine Delivery Systems (ENDS) on Pulmonary Health in Teenagers.
- ClinicalTrials.gov ID
- NCT05105555
- Acronym / sponsor ID
- e-BILD / YTCR3419
- Conditions
- Vaping, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- None, except for general exclusion criteria of BILD study (NCT04286464)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of the respiratory symptom coughing with vaping status (validated by exposure markers)
Time frame: 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)
Time frame: 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
8 secondary outcomes
Correlation of validated vaping status with lung function (spirometry) in healthy teenagers
Time frame: At baseline
Correlation of validated vaping status with lung function (bodyplethysmography) in healthy teenagers
Time frame: At baseline
Correlation of lung function (multiple breath washout) in healthy teenagers
Time frame: At baseline
Correlation of validated vaping status with airway inflammation (exhaled nitric oxide) in healthy teenagers.
Time frame: At baseline
Correlation of validated vaping status with lung structure (magnetic resonance imaging, MRI) in healthy teenagers.
Time frame: At baseline
Correlation of validated vaping status with measures of oxidative stress in healthy teenagers.
Time frame: At baseline
Correlation of validated vaping status with ex vivo immune response of nasal epithelial cells in healthy teenagers.
Time frame: At baseline
Role of nicotine metabolism on lung health indicators.
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian Jakob, MD principal investigator
Institute of Primary Health Care BIHAM, Bern University
Reto Auer, MD, MAS principal investigator
Institute of Primary Health Care BIHAM, Bern University
Philipp Latzin, MD, PhD principal investigator
Inselspital, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaping and Lung Diseases, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of the respiratory symptom coughing with vaping status (validated by exposure markers) (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.