Biomarkers and Respiratory Omics as New CHildren Opportunities - Study of Clinical Outcomes and Predictivity Evaluation
NCT ID: NCT07232550
Last Updated: 2025-11-18
Study Results
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Basic Information
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NOT_YET_RECRUITING
160 participants
OBSERVATIONAL
2025-11-30
2035-12-31
Brief Summary
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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.
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Detailed Description
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Participants will be recruited from the Pediatric Pulmonology Departments of the Medical Universities in Warsaw and Lodz. At baseline, investigators will administer a standardized medical questionnaire approved by both medical centers. All participants will undergo a single fiberoptic bronchoscopy during hospitalization according to clinical indications and with informed consent. During bronchoscopy, bronchoalveolar lavage (BAL) fluid samples will be collected for metagenomic, metabolomic, culture, biochemical, and cytological analyses. Additional mucosal biopsies will be obtained with separate consent if applicable.
Follow-up visits will include blood sample collection, sputum sampling (for cooperative children), spirometry, impulse oscillometry, and Fractional Exhaled Nitric Oxide measurements, without repeat bronchoscopy. The bronchoscopy procedure will not be repeated.
The study involves analysis of biological samples obtained during clinically indicated bronchoscopy, followed by a 5-year observation period. The findings will aid in distinguishing asthma phenotypes, identifying risk factors for asthma and protracted bacterial bronchitis, and improving the understanding of factors contributing to poor treatment response in these conditions.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Asthma
Children diagnosed with asthma at the baseline
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
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
Respiratory functional tests
At baseline and during each follow-up visit children will perform spirometry, Impulse Oscillometry and Fractional Exhaled Nitric Oxide
Sputum culture
At baseline and during first follow-up visit sputum will be collected from each individual for culture
Protracted Bacterial Bronchitis
Children diagnosed with Protracted Bacterial Bronchitis at the baseline
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
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
Respiratory functional tests
At baseline and during each follow-up visit children will perform spirometry, Impulse Oscillometry and Fractional Exhaled Nitric Oxide
Sputum culture
At baseline and during first follow-up visit sputum will be collected from each individual for culture
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
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
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
Respiratory functional tests
At baseline and during each follow-up visit children will perform spirometry, Impulse Oscillometry and Fractional Exhaled Nitric Oxide
Sputum culture
At baseline and during first follow-up visit sputum will be collected from each individual for culture
Non inflammatory causes of chronic cough
Children diagnosed with: laryngomalacia, tracheobronchomalacia adenoid hypertrophy, gastroesophageal reflux disease, habitual cough
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
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
Respiratory functional tests
At baseline and during each follow-up visit children will perform spirometry, Impulse Oscillometry and Fractional Exhaled Nitric Oxide
Sputum culture
At baseline and during first follow-up visit sputum will be collected from each individual for culture
Control group
Children without underlying diseases who undergo bronchoscopy either for suspected foreign body aspiration or as part of routine diagnostic evaluation
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
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
Respiratory functional tests
At baseline and during each follow-up visit children will perform spirometry, Impulse Oscillometry and Fractional Exhaled Nitric Oxide
Sputum culture
At baseline and during first follow-up visit sputum will be collected from each individual for culture
Interventions
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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
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
Respiratory functional tests
At baseline and during each follow-up visit children will perform spirometry, Impulse Oscillometry and Fractional Exhaled Nitric Oxide
Sputum culture
At baseline and during first follow-up visit sputum will be collected from each individual for culture
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
17 Years
ALL
No
Sponsors
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Medical University of Lodz
OTHER
Medical University of Bialystok
OTHER
Medical University of Warsaw
OTHER
Responsible Party
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Principal Investigators
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Wojciech Feleszko, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Warsaw
Central Contacts
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References
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Other Identifiers
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KB/100/2025
Identifier Type: -
Identifier Source: org_study_id
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