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)

December 16, 2022 updated by: Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica

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.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment decision at the last visit
Time Frame: 90 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma exacerbations
Time Frame: 90 days
Occurrence of asthma exacerbations in the time interval between the baseline and the last visit.
90 days
CACT-ACT
Time Frame: 90 days
Childhood Asthma Control Test (C-ACT, for children aged 6-11) or Asthma Control Test (ACT, for children aged 12-16). The total score ranges from 0 (poor asthma control) to 27 (optimal asthma control).
90 days
Treatment adherence
Time Frame: Day 0; 90 days
Change in urinary cortisol levels (last vs baseline visit);
Day 0; 90 days
Treatment adherence
Time Frame: 90 days
9-item Medication Adherence Rating Scale (MARS-9). The total score ranges from 5 to 45. Higher scores indicate higher self-reported adherence.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

May 31, 2024

Study Completion (Anticipated)

May 31, 2024

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

December 19, 2022

Last Update Submitted That Met QC Criteria

December 16, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma in Children

Clinical Trials on Pneumopipe® (European patent 12425057.2, Rome, Italy)

3
Subscribe