- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04326530
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)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Stefania La Grutta, MD
- Phone Number: 0916809194
- Email: stefania.lagrutta@irib.cnr.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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:
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.
|
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
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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