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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-24

Study Completion Date

2018-08-03

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.

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Detailed Description

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Conditions

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Asthma Healthy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Assessment of E-nose measurements

Intervention Type OTHER

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).

Assessment of E-nose measurements

Intervention Type OTHER

Breath sampling through E-nose pneumopipe

Interventions

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Assessment of E-nose measurements

Breath sampling through E-nose pneumopipe

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

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.

Exclusion Criteria

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Stefania La Grutta, MD

MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.

Responsibility Role PRINCIPAL_INVESTIGATOR