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

NCT04326530 | Unknown

• 1 other identifier: 3/2020
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Treatment decision at the last visit

  ICS dose step-down (type-1 mismatching, i.e. unexpectedly good prognosis), same ICS dose (perfect matching, i.e. expected prognosis) or ICS dose step-up (type-2 mismatching, i.e. unexpectedly bad prognosis).

  90 days

Secondary Outcomes (4)

• Asthma exacerbations

  90 days

• CACT-ACT

  90 days

• Treatment adherence

  Day 0; 90 days

• Treatment adherence

  90 days

Study Arms (1)

Persistent asthmatic children

150 steroid-naive, persistent asthmatic children enrolled during their first consultation at the IRIB-CNR outpatient clinic. They will underwent three visits: 1. screening visit (-2 days); 2. baseline visit (day 0); 3. last visit (+90 days). They will be treated with controller medications according to GINA recommendations (http://ginasthma.org).

Device: Pneumopipe® (European patent 12425057.2, Rome, Italy); Other: Other assessments

Interventions

Pneumopipe® (European patent 12425057.2, Rome, Italy) DEVICE

Collection of VOCs on a cartridge after that the child has normally breathed in it for 3 min, both at the baseline and at the last visit.

Persistent asthmatic children

Other assessments OTHER

* Spirometry, both at the baseline and at the last visit. * 24-hour urine collection, both at the baseline and at the last visit.

Persistent asthmatic children

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

150 steroid-naive, persistent asthmatic children enrolled during their first consultation at the IRIB-CNR outpatient clinic.

You may qualify if:

• male or female gender
• age between 6 and 16 years
• first asthma diagnosis according to GINA recommendations (http://ginasthma.org), including assessment of the history of respiratory symptoms (wheezing, shortness of breath, chest tightness and cough) and environmental exposures (smoke, mold, vehicular traffic), spirometry (FEV1/FVC\<0.90 at baseline, \>12% FEV1 increase from baseline after bronchodilator inhalation) and skin prick tests.

You may not qualify if:

• exacerbations requiring oral corticosteroids in the last four weeks
• use of controller medications (leukotriene receptor antagonists and/or inhaled corticosteroids) in the last four weeks
• respiratory infections in the last four weeks
• immunological, metabolic, cardiac or neurological diseases
• major malformations of the respiratory system
• active smoking.

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead
• Campus Bio-Medico University: collaborator

Related Publications (1)

• Fasola S, Ferrante G, Sabatini A, Santonico M, Zompanti A, Grasso S, Antonelli Incalzi R, La Grutta S. Repeatability of exhaled breath fingerprint collected by a modern sampling system in asthmatic and healthy children. J Breath Res. 2019 May 1;13(3):036007. doi: 10.1088/1752-7163/ab1765.

  PMID: 30965288 BACKGROUND

Central Study Contacts

Stefania La Grutta, MD

CONTACT

0916809194; stefania.lagrutta@irib.cnr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: February 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share