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NCT07232550

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

Sponsor: Medical University of Warsaw

View on ClinicalTrials.gov

Summary

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.

Official title: Biomarkers and Respiratory Omics as New CHildren Opportunities - Study of Clinical Outcomes and Predictivity Evaluation - a Multi-cohort, Multi-center Study

Key Details

Gender

All

Age Range

Any - 17 Years

Study Type

OBSERVATIONAL

Enrollment

160

Start Date

2025-11

Completion Date

2035-12

Last Updated

2025-11-18

Healthy Volunteers

Conditions

Asthma in Children Protracted Bacterial Bronchitis Chronic Cough

Interventions

PROCEDURE

fiberoptic bronchoscopy

During procedure performing physician will evaluate respiratory tract anatomy. Samples of bronchoalveolar lavage fluid will be collected for culture, cellular composition analysis, amphiregulin level, cytokine profiling, metagenomic sequencing, metabolomic assessment, additionally mucosal biopsy will be performed using forceps and brush techniques for histopathological evaluation

PROCEDURE

blood sample collection

5 mL sample of blood will be collected in each individual at baseline and during follow-up visits for complete blood count and Immunoglobulin E levels

DIAGNOSTIC_TEST

Respiratory functional tests

At baseline and during each follow-up visit children will perform spirometry, Impulse Oscillometry and Fractional Exhaled Nitric Oxide

DIAGNOSTIC_TEST

Sputum culture

At baseline and during first follow-up visit sputum will be collected from each individual for culture

Inclusion Criteria: * Age at the beginning of the study 0-17 years old * Clinical indication and qualification by the attending physician for fiberoptic bronchoscopy under general anesthesia: * Obstruction of the airways: * 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) * Radiological findings located in the course of the larynx, trachea or bronchi * Persistent atelectasis on subsequent radiological examinations * Persistent cough \>4 weeks * Hemoptysis * Suspected laryngomalacia or tracheobronchomalacia * Suspected tracheoesophageal fistula * Persistent dyspnea unresponsive to anti-asthmatic treatment used for min. 2 months, with no other identifiable causes * Radiologically detected mediastinal abnormalities * Suspected presence of a vascular ring * Presence of excessive secretions that are impossible for the patient to expectorate * Fine needle biopsy of cystic lesions * Obtained consent from patient/legal guardian for participation in the study Exclusion Criteria: * 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 * Children with diagnosed respiratory diseases other than asthma and protracted bacterial bronchitis - including interstitial diseases, tuberculosis, inflammation of small and medium-sized blood vessels * Patients for whom \>48 hours have passed between suspicion of foreign body aspiration and interventional bronchoscopy * Children with foreign body aspiration having a foreign body located in the trachea

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria