Skip to main content
OpenTrials
Completed

NCT Number: NCT03025061

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Healthy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Palermo, Sicily, 90146, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assessment of E-nose measurements

Other

Breath sampling through E-nose pneumopipe

Primary outcomes

  1. Electronic nose measurements

    Time frame: 1 week

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

Secondary outcomes

  1. Fraction of Exhaled Nitric Oxide (FeNO)

    Time frame: 1 week

  2. Pulmonary function (FEV1, FVC, etc.)

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Collaborators

  • Campus Bio-Medico University

Registry information

Official study title

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

Acronym: CERS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 19, 2017
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.