Ignite Creation Date:
2024-05-06 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05105555
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2021-09-20
Brief Title:
The e-BILD Study Effects of E-cigarettes on Lung Health in Teenagers
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
The e-BILD Study Effects of Electric Nicotine Delivery Systems ENDS on Pulmonary Health in Teenagers
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
e-BILD
Brief Summary:
Electronic nicotine delivery systems ENDSe-cigarettesvaping 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 indicators isare 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 controls1 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
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 controls1 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None