Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-01-18 @ 8:09 AM
Study NCT ID:
NCT03025061
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2017-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Asthma
Sponsor:
Istituto per la Ricerca e l'Innovazione Biomedica
Organization:
Study Overview
Official Title:
Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Moderate Asthma
Status:
COMPLETED
Status Verified Date:
2018-09
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:
CERS
Brief Summary:
"Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Moderate Asthma" is an observational prospective study in outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR), Italy.
The electronic nose (E-nose) has been proposed as a novel, non-invasive tool to evaluate the level of airway inflammation for different respiratory diseases, especially in children. To date, there are no data on the within-day and the between-day repeatability of the breath pattern in healthy children and in children with moderate asthma.
The breath pattern will be analyzed by collecting, for each child, three samples of the breath through the E-nose. Within-day repeatability will be assessed using two consecutive measurements (the second one after 30 minutes). Between-day repeatability will be assessed using a third measurement repeated after 7 days.
The study is expected to provide information about the accuracy of E-nose measurements for a child population.
The electronic nose (E-nose) has been proposed as a novel, non-invasive tool to evaluate the level of airway inflammation for different respiratory diseases, especially in children. To date, there are no data on the within-day and the between-day repeatability of the breath pattern in healthy children and in children with moderate asthma.
The breath pattern will be analyzed by collecting, for each child, three samples of the breath through the E-nose. Within-day repeatability will be assessed using two consecutive measurements (the second one after 30 minutes). Between-day repeatability will be assessed using a third measurement repeated after 7 days.
The study is expected to provide information about the accuracy of E-nose measurements for a child population.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: