Study of Biomarkers and Respiratory Omics in Children Evaluating Clinical Outcomes and Predicting Disease Progression in Asthma, Protracted Bacterial Bronchitis, and Chronic Cough

What this Trial Is About

This observational study focuses on children aged 0 to 17 years with asthma, protracted bacterial bronchitis, chronic cough, or exposure to inhaled glucocorticosteroids without an asthma diagnosis. It aims to improve identification of biomarkers that predict disease progression and assess the effectiveness of current therapies. The study involves multiple groups of children based on medical history and evaluates the microbiome, cellular composition, and metabolomic profiles related to respiratory conditions. Participants will undergo a single fiberoptic bronchoscopy during hospitalization, where samples of bronchoalveolar lavage fluid and mucosal biopsies with separate consent are collected for detailed analyses including metagenomic, metabolomic, culture, and histopathological studies. Follow-up visits over five years will include blood sample collection, sputum sampling when possible, and respiratory function tests such as spirometry, impulse oscillometry, and Fractional Exhaled Nitric Oxide measurements, without repeating bronchoscopy. Throughout the study, researchers will collect medical history, demographic data, and environmental exposure information to understand disease progression and treatment response. The primary outcomes include evaluating microbiome and metabolomic profiles immediately after bronchoscopy and correlating these findings with treatment and disease course over two years. Secondary outcomes involve assessments up to five years for asthma control, pathogen prevalence, antibiotic resistance, and personalized treatment possibilities. Total participation includes an initial procedure and long-term monitoring up to five years.

Biomarkers and Respiratory Omics as New CHildren Opportunities - Study of Clinical Outcomes and Predictivity Evaluation