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

NCT03025061 | Completed DMC

• 1 other identifier: 5/2016
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Healthy

Keywords

Breath pattern; Children; Repeatability

Outcome Measures

Primary Outcomes (1)

• Electronic nose measurements

  Several volatile organic compounds, including isoprene, 1,2-pentadiene, acetone, ethanol, pentane and ethane, identified in exhaled breath.

  1 week

Secondary Outcomes (2)

• Fraction of Exhaled Nitric Oxide (FeNO)

  1 week

• Pulmonary function (FEV1, FVC, etc.)

  1 week

Study Arms (2)

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

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

Interventions

Assessment of E-nose measurements OTHER

Breath sampling through E-nose pneumopipe

15 children with moderate asthma; 30 healthy children

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Moderate asthma (GINA 2015);
• Age 6-11 years;
• No upper airway respiratory infections or exacerbations in the last 4 weeks;
• Steroid-naive asthma;
• Positive bronchodilator response;
• Non smoker.
• Age 6-11 years;
• No upper airway respiratory infections in the last 4 weeks;
• Non smoker;
• No history of asthma and respiratory diseases during the life;
• Negative bronchodilator response.

You may not qualify if:

• Symptoms of acute respiratory infection;
• Immunological and metabolic systemic disease;
• Major malformations of the upper airways;
• Active smoker.

Sponsors & Collaborators

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

Study Sites (1)

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Palermo, Sicily, 90146, Italy

Location

Related Publications (1)

• 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.

  PMID: 30965288 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 19, 2017
• Study Start: February 24, 2017
• Primary Completion: August 3, 2018
• Study Completion: August 3, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)