Skip to content

Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Asthma

Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Moderate Asthma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03025061
Acronym
CERS
Enrollment
45
Registered
2017-01-19
Start date
2017-02-24
Completion date
2018-08-03
Last updated
2018-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Healthy

Keywords

Breath pattern, Children, Repeatability

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.

Interventions

OTHERAssessment of E-nose measurements

Breath sampling through E-nose pneumopipe

Sponsors

Campus Bio-Medico University
CollaboratorOTHER
Istituto per la Ricerca e l'Innovazione Biomedica
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No

Inclusion criteria

The inclusion criteria for asthmatic children are: 1. Moderate asthma (GINA 2015); 2. Age 6-11 years; 3. No upper airway respiratory infections or exacerbations in the last 4 weeks; 4. Steroid-naive asthma; 5. Positive bronchodilator response; 6. Non smoker. The inclusion criteria for healthy children are: 1. Age 6-11 years; 2. No upper airway respiratory infections in the last 4 weeks; 3. Non smoker; 4. No history of asthma and respiratory diseases during the life; 5. Negative bronchodilator response. The

Exclusion criteria

are: 1. Symptoms of acute respiratory infection; 2. Immunological and metabolic systemic disease; 3. Major malformations of the upper airways; 4. Active smoker.

Design outcomes

Primary

MeasureTime frameDescription
Electronic nose measurements1 weekSeveral volatile organic compounds, including isoprene, 1,2-pentadiene, acetone, ethanol, pentane and ethane, identified in exhaled breath.

Secondary

MeasureTime frame
Fraction of Exhaled Nitric Oxide (FeNO)1 week
Pulmonary function (FEV1, FVC, etc.)1 week

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026