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

Istituto per la Ricerca e l'Innovazione Biomedica

Status: Completed

Conditions: Healthy; Asthma

Treatments: Other: Assessment of E-nose measurements

Study type: Observational

Funder types: Other

Identifiers

NCT03025061

5/2016

Details and patient eligibility

About

"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.

Enrollment: 45 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

45 participants in 2 patient groups

15 children with moderate asthma

Description:

Assessment of E-nose measurements: three E-nose measurements on 15 children with moderate asthma (of both sex and 6-11 years old): first measurement, second one after 30 minutes, third one after 7 days. These children attend the 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).

Treatment:

Other: Assessment of E-nose measurements

30 healthy children

Description:

Assessment of E-nose measurements: three E-nose measurements on 30 healthy children (of both sex and 6-11 years old): first measurement, second one after 30 minutes, third one after 7 days. These children attend the primary schools involved in the municipal project "Educational Pathways" (Palermo).

Treatment:

Other: Assessment of E-nose measurements