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

Sponsor
Medical University of Warsaw
Study ID
NCT07232550
Status
Recruiting
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Conditions

  • Asthma in Children
  • Chronic Cough
  • Protracted Bacterial Bronchitis

Eligibility Criteria

Sex
ALL
Age
N/A - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • fiberoptic bronchoscopy — PROCEDURE
    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
  • blood sample collection — PROCEDURE
    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
  • Respiratory functional tests — DIAGNOSTIC_TEST
    At baseline and during each follow-up visit children will perform spirometry, Impulse Oscillometry and Fractional Exhaled Nitric Oxide
  • Sputum culture — DIAGNOSTIC_TEST
    At baseline and during first follow-up visit sputum will be collected from each individual for culture

Study Details

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.

Key Dates

First listed
Nov 18, 2025
Start date
Mar 6, 2026
Status verified
Sep 2025
Primary completion
Dec 31, 2035
Completion
Dec 31, 2035

Study Design

Enrollment
160 participants (estimated)

Arms

  • Arm: Asthma
    Children diagnosed with asthma at the baseline
  • Arm: Protracted Bacterial Bronchitis
    Children diagnosed with Protracted Bacterial Bronchitis at the baseline
  • Arm: Children without asthma who have been exposed to inhaled glucocorticosteroids
    Children without asthma who have been exposed to inhaled glucocorticosteroids for at least 4 weeks during the 2 months preceeding bronchoscopy
  • Arm: Non inflammatory causes of chronic cough
    Children diagnosed with: laryngomalacia, tracheobronchomalacia adenoid hypertrophy, gastroesophageal reflux disease, habitual cough
  • Arm: Control group
    Children without underlying diseases who undergo bronchoscopy either for suspected foreign body aspiration or as part of routine diagnostic evaluation

Primary Outcome Measure

Evaluation on microbiome composition and diversity, cellular composition, and metabolomic profile between study groups [ Time Frame: Index hospitalization, immediately after the procedure ]

Central Contacts

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