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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy, Asthma

Intervention / Treatment
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* Other: Assessment of E-nose measurements


Participation Criteria
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Eligibility Criteria
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The inclusion criteria for asthmatic children are: 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. The inclusion criteria for healthy children are: 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. The exclusion criteria are: Symptoms of acute respiratory infection; Immunological and metabolic systemic disease; Major malformations of the upper airways; Active smoker.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 15 children with moderate asthma<br>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<br>* Breath sampling through E-nose pneumopipe<br>|
| 30 healthy children<br>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<br>* Breath sampling through E-nose pneumopipe<br>|

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of Exhaled Nitric Oxide (FeNO) |  | 1 week | 
| Pulmonary function (FEV1, FVC, etc.) |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Breath pattern, Repeatability