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

NCT07232550 | Not Yet Recruiting

• 1 other identifier: KB/100/2025
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

PBB; Asthma

Outcome Measures

Primary Outcomes (2)

• Evaluation on microbiome composition and diversity, cellular composition, and metabolomic profile between study groups

  16S rRNA targeted sequencing, Shannon index, Chao1, and Pielou's evenness, Bray-Curtis dissimilarity, weighted UniFrac and unweighted UniFrac measures, PERMANOVA, principal coordinate analysis, ANCOM-BC2, ASVs tables generated by QIIME2 will be used as input for PICRUSt2 to infer functional profiles of the microbiomes, Biocrates' MetIDQ and MetaboAnalystR R package

  Index hospitalization, immediately after the procedure

• Correlation of metagenomic and metabolomic findings on subsequent treatment and disease course between groups

  16S rRNA targeted sequencing, Shannon index, Chao1, and Pielou's evenness, Bray-Curtis dissimilarity, weighted UniFrac and unweighted UniFrac measures, PERMANOVA, principal coordinate analysis, ANCOM-BC2, ASVs tables generated by QIIME2 will be used as input for PICRUSt2 to infer functional profiles of the microbiomes, Biocrates' MetIDQ and MetaboAnalystR R package, MANOVA and logistic regression, Cox proportional hazards model

  2 years

Secondary Outcomes (17)

• Comparison of the previous medical history and demographic characteristics across the study groups

  At baseline

• Assessment of the degree of asthma control among children diagnosed with asthma according to Global Initiative for Asthma

  5 years

• Evaluation how the place of residence influences the incidence and clinical course of the studied diseases

  5 years

• Assessment of exposure to PM10 dust at the place of residence during the year preceding study inclusion in children from each group

  At baseline

• Comparison of the normalized difference vegetation index (NDVI) and chlorophyll index (CI) green levels between study groups at baseline

  At baseline

Study Arms (5)

Asthma

Children diagnosed with asthma at the baseline

Procedure: fiberoptic bronchoscopy; Procedure: blood sample collection; Diagnostic Test: Respiratory functional tests; Diagnostic Test: Sputum culture

Protracted Bacterial Bronchitis

Children diagnosed with Protracted Bacterial Bronchitis at the baseline

Procedure: fiberoptic bronchoscopy; Procedure: blood sample collection; Diagnostic Test: Respiratory functional tests; Diagnostic Test: Sputum 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

Procedure: fiberoptic bronchoscopy; Procedure: blood sample collection; Diagnostic Test: Respiratory functional tests; Diagnostic Test: Sputum culture

Non inflammatory causes of chronic cough

Children diagnosed with: laryngomalacia, tracheobronchomalacia adenoid hypertrophy, gastroesophageal reflux disease, habitual cough

Procedure: fiberoptic bronchoscopy; Procedure: blood sample collection; Diagnostic Test: Respiratory functional tests; Diagnostic Test: Sputum culture

Control group

Children without underlying diseases who undergo bronchoscopy either for suspected foreign body aspiration or as part of routine diagnostic evaluation

Procedure: fiberoptic bronchoscopy; Procedure: blood sample collection; Diagnostic Test: Respiratory functional tests; Diagnostic Test: Sputum culture

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

Asthma; Children without asthma who have been exposed to inhaled glucocorticosteroids; Control group; Non inflammatory causes of chronic cough; Protracted Bacterial Bronchitis

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

Asthma; Children without asthma who have been exposed to inhaled glucocorticosteroids; Control group; Non inflammatory causes of chronic cough; Protracted Bacterial Bronchitis

Respiratory functional tests DIAGNOSTIC_TEST

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

Asthma; Children without asthma who have been exposed to inhaled glucocorticosteroids; Control group; Non inflammatory causes of chronic cough; Protracted Bacterial Bronchitis

Sputum culture DIAGNOSTIC_TEST

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

Asthma; Children without asthma who have been exposed to inhaled glucocorticosteroids; Control group; Non inflammatory causes of chronic cough; Protracted Bacterial Bronchitis

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from among patients hospitalized in the University Clinical Center of the Medical University of Warsaw, Department of Pediatric Pulmonology and Allergology, and in the Medical University of Lodz, Department of Pediatric Pulmonology

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Medical University of Lodz: collaborator
• Medical University of Bialystok: collaborator

Related Publications (30)

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Biospecimen

Retention: SAMPLES WITH DNA

bronchoalveolar lavage fluid; sputum; mucosal biopsy; whole blood sample

MeSH Terms

Conditions

Chronic Cough; Asthma

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Wojciech Feleszko, MD, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomasz Kopiec, MD

CONTACT

+48505300599; tomasz.kopiec@wum.edu.pl

Aleksander Adamiec, MD

CONTACT

+48606349502; aleksander.adamiec@wum.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: November 18, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: November 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share