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

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

"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.

Study Overview

• Status: Completed
• Conditions: Healthy; Asthma
• Intervention / Treatment: Other: Assessment of E-nose measurements

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Italy
  • Sicily
    • Palermo, Sicily, Italy, 90146
      • Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A study population of 15 asthmatic children (moderate asthma) attending 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).

A control group of healthy children (n=30), recruited from the primary schools involved in the municipal project "educational pathways" (Palermo, Italy) to which the PAP group partecipates.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
15 children with moderate asthma; 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).	Other: Assessment of E-nose measurements; Breath sampling through E-nose pneumopipe
30 healthy children; 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).	Other: Assessment of E-nose measurements; Breath sampling through E-nose pneumopipe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electronic nose measurements	Several volatile organic compounds, including isoprene, 1,2-pentadiene, acetone, ethanol, pentane and ethane, identified in exhaled breath.	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Fraction of Exhaled Nitric Oxide (FeNO)	1 week
Pulmonary function (FEV1, FVC, etc.)	1 week

Collaborators and Investigators

• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
• Collaborators: Campus Bio-Medico University

Publications and helpful links

General Publications

• Fasola S, Ferrante G, Sabatini A, Santonico M, Zompanti A, Grasso S, Antonelli Incalzi R, La Grutta S. Repeatability of exhaled breath fingerprint collected by a modern sampling system in asthmatic and healthy children. J Breath Res. 2019 May 1;13(3):036007. doi: 10.1088/1752-7163/ab1765.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2017
• Primary Completion (Actual): August 3, 2018
• Study Completion (Actual): August 3, 2018

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: January 16, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Children; Repeatability; Breath pattern
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 5/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO