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

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.

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

Sponsors & Collaborators

• Medical University of Lodz

  collaborator OTHER

• Medical University of Bialystok

  collaborator OTHER

• Medical University of Warsaw

  lead OTHER

Principal Investigators

• Wojciech Feleszko, MD, PhD · Medical University of Warsaw

Eligibility

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-30

Primary Completion

2035-12-31

Completion

2035-12-31