Status:
UNKNOWN
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
Lead Sponsor:
Istituto per la Ricerca e l'Innovazione Biomedica
Collaborating Sponsors:
Campus Bio-Medico University
Conditions:
Asthma in Children
Eligibility:
All Genders
6-16 years
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04326530
Start Date
February 1 2023
End Date
May 31 2024
Last Update
December 19 2022
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