Use of a Modern Breath Sampling System (the Pneumopipe® Combined With an Array of E-nose Sensors) for the Prediction of Treatment Response in Persistent Asthmatic Children — Pneumo-Pred  

Asthma in Children Clinical Trial

Official title: Use of a Modern Breath Sampling System (the Pneumopipe® Combined With an Array of E-nose Sensors) for the Prediction of Treatment Response in Persistent Asthmatic Children

Status Not yet recruiting

Clinical Trial Summary

Due to a large disease heterogeneity, the proper management of childhood asthma may be a challenging task. Despite the screening of lung function is a fundamental tool, spirometry alone may not allow a reliable prediction of the disease prognosis, such as treatment response and asthma exacerbations.

Recently, it has been shown that the detection of volatile organic compounds (VOCs) in exhaled breath (Breathomics) is able to predict asthma exacerbations and to discriminate children with persistently controlled asthma from those with uncontrolled asthma. These studies have been realized through gas chromatography / mass spectroscopy techniques, which also provide information on specific compounds useful for pathophysiologic research; however, they are expensive and time consuming.

An alternative approach, scarcely adopted so far, is based on cross-reactive nonspecific sensor arrays (e-noses), which may provide valuable information on disease status through pattern recognition algorithms or discriminant analyses of the global sensor response pattern (breath-fingerprint). In particular, the Pneumopipe® (European patent 12425057.2, Rome, Italy) is a recent and innovative device allowing direct absorption of VOCs on a cartridge after an individual has normally breathed in it for 3 min. It is a very simple and cheap procedure, suitable for non-collaborative populations. Moreover, cartridges may be preferable over sampling bags in terms of preservation and transportability. This modern breath sampling system provides repeatable measurements, and negligible overlap has been observed with information provided by spirometry.

The main objective of the present study is to assess whether baseline (pre-treatment) spirometry and e-nose measurements may predict asthma prognosis in persistent asthmatic children, in terms of response to the prescribed treatment with inhaled steroid (ICS), and to provide simple rules for discriminating treatment responders and non-responders. The secondary aim is to assess e-nose ability to predict asthma exacerbations, disease control and adherence.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

• NCT number: NCT04326530
• Study type: Observational
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: Stefania La Grutta, MD
• Phone: 0916809194
• Email: stefania.lagrutta@irib.cnr.it
• Status: Not yet recruiting
• Start date: February 1, 2023
• Completion date: May 31, 2024