Asthma in ChildrenPneumo-PredNCT04326530
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
An observational study of Asthma in Children, run by Istituto per la Ricerca e l'Innovazione Biomedica.
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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Pneumopipe® (European patent 12425057.2, Rome, Italy) and Other assessments
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: 150 steroid-naive, persistent asthmatic children enrolled during their first consultation at the IRIB-CNR outpatient clinic.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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
- Being tested
- Pneumopipe® (European patent 12425057.2, Rome, Italy), Other assessments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Other assessmentsOther
- Spirometry, both at the baseline and at the last visit.
- 24-hour urine collection, both at the baseline and at the last visit.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Pneumopipe® (European patent 12425057.2, Rome, Italy); Other: Other assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 90 days
Secondary outcomes (4)
Asthma exacerbations
Occurrence of asthma exacerbations in the time interval between the baseline and the last visit.
Measured: 90 days
CACT-ACT
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).
Measured: 90 days
Treatment adherence
Change in urinary cortisol levels (last vs baseline visit);
Measured: Day 0; 90 days
Treatment adherence
9-item Medication Adherence Rating Scale (MARS-9). The total score ranges from 5 to 45. Higher scores indicate higher self-reported adherence.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start1 Feb 2023 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Collaborators
- Campus Bio-Medico University
- Responsible party
- Principal investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326530
- Sponsor's protocol ID
- 3/2020
- Acronym
- Pneumo-Pred
- Status last verified
- Dec 2022
- First submitted
- 26 Mar 2020
- Last updated
- 19 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30965288
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04326530
- Acronym / sponsor ID
- Pneumo-Pred / 3/2020
- Conditions
- Asthma in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Campus Bio-Medico University
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persistent asthmatic children | – | Device: Pneumopipe® (European patent 12425057.2, Rome, Italy), Other: Other assessments150 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). |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 150 steroid-naive, persistent asthmatic children enrolled during their first consultation at the IRIB-CNR outpatient clinic.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumopipe® (European patent 12425057.2, Rome, Italy)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. | Device | Persistent asthmatic children |
| Other assessments* Spirometry, both at the baseline and at the last visit. * 24-hour urine collection, both at the baseline and at the last visit. | Other | Persistent asthmatic children |
Primary outcome
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).
4 secondary outcomes
Asthma exacerbations
Time frame: 90 days
CACT-ACT
Time frame: 90 days
Treatment adherence
Time frame: Day 0; 90 days
Treatment adherence
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Background: PubMed 30965288Fasola 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children, run by Istituto per la Ricerca e l'Innovazione Biomedica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefania La Grutta, MD (0916809194, stefania.lagrutta@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment decision at the last visit (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04326530, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.