About this trial
The goal of this observational study is to improve the identification of biomarkers that predict disease progression and to assess the effectiveness of current therapies in children with asthma and protracted bacterial bronchitis.
The main aim of the study is to evaluate the microbiome composition and diversity, cellular composition, and metabolomic profile. In addition, to assess their correlation on subsequent treatment and disease course in children with asthma, protracted bacterial bronchitis, and in those receiving inhaled glucocorticosteroids without a diagnosis of asthma.
Participants will undergo fiberoptic bronchoscopy. During bronchoscopy, the performing physician will collect Bronchoalveolar lavage fluid samples for metagenomic and metabolomic analysis, as well as mucosal biopsies for histopathological evaluation.
Eligibility criteria
Qualifiers
Age at the beginning of the study 0-17 years old
Suspicion of foreign body aspiration
Persistent stridor
Abnormal result of functional tests of respiratory system - flattening of inspiratory or expiratory curve, presence of restriction (tested vital capacity <5 percentile) or irreversible obstruction (persistence of Tiffneau index <5 percentile despite administration of bronchodilators)
Disqualifiers
Active acute respiratory infection up to 4 weeks before the procedure
Taking antibiotics or systemic glucocorticosteroids up to 4 weeks before the procedure
Patients with very severe comorbidities (congenital immunodeficiencies, genetic disorders, neurological or neuromuscular diseases, cancer, severe congenital heart defects, heart failure, liver failure, inflammatory bowel disease, celiac disease)
Patients with blood clotting disorders
Trial design
Treatments tested in this trial
- fiberoptic bronchoscopy
- blood sample collection
- Respiratory functional tests
- Sputum culture
Treatment groups
Locations
Sponsors and collaborators
Medical University of Warsaw
Lead sponsor
Medical University of Lodz
Collaborator
Medical University of Bialystok
Collaborator