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

Healthy Clinical Trial

— CERS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025061
• Other study ID #: 5/2016
• Status: Completed
• Start date: February 24, 2017
• Est. completion date: August 3, 2018

Study information

• Verified date: September 2018
• Source: Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 3, 2018
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Healthy

Intervention

Other:
• Assessment of E-nose measurements
Breath sampling through E-nose pneumopipe

Locations

Country	Name	City	State
Italy	Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council	Palermo	Sicily

Sponsors (2)

Lead Sponsor	Collaborator
Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy	Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electronic nose measurements	Several volatile organic compounds, including isoprene, 1,2-pentadiene, acetone, ethanol, pentane and ethane, identified in exhaled breath.	1 week
Secondary	Fraction of Exhaled Nitric Oxide (FeNO)		1 week
Secondary	Pulmonary function (FEV1, FVC, etc.)		1 week