Recruiting

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

ClinicalTrials.gov IDNCT07232550

PhaseNot Applicable

Enrollment160

SponsorMedical University of Warsaw

AgeNo minimum reported

SexALL

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Conditions studied

Asthma in Children, Protracted Bacterial Bronchitis, Chronic Cough

About this study

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.

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

Primary outcomes

Evaluation on microbiome composition and diversity, cellular composition, and metabolomic profile between study groups (Index hospitalization, immediately after the procedure)
Correlation of metagenomic and metabolomic findings on subsequent treatment and disease course between groups (2 years)

Eligibility information

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

Study locations

Żwirki i Wigury 63A, Warsaw, 02-091 Poland

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.