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

November 14, 2025 updated by: Medical University of Warsaw

Biomarkers and Respiratory Omics as New CHildren Opportunities - Study of Clinical Outcomes and Predictivity Evaluation - a Multi-cohort, Multi-center 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective cohort study will enroll 160 participants and allocate them into study arms according to their medical history. The planned arms include: children with asthma, children with protracted bacterial bronchitis, children without asthma who are exposed to inhaled glucocorticosteroids, children with chronic cough, and a control group.

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.

Study Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asthma
Children diagnosed with asthma at the baseline
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
Protracted Bacterial Bronchitis
Children diagnosed with Protracted Bacterial Bronchitis at the baseline
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
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
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
Non inflammatory causes of chronic cough
Children diagnosed with: laryngomalacia, tracheobronchomalacia adenoid hypertrophy, gastroesophageal reflux disease, habitual cough
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation on microbiome composition and diversity, cellular composition, and metabolomic profile between study groups
Time Frame: Index hospitalization, immediately after the procedure
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
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the previous medical history and demographic characteristics across the study groups
Time Frame: At baseline
MANOVA, neural networks and logistic regression
At baseline
Assessment of the degree of asthma control among children diagnosed with asthma according to Global Initiative for Asthma
Time Frame: 5 years
In children aged ≥5 years using the Asthma Control Questionnaire (ACQ) numeric scale, and in children <5 years using a questionnaire assessing the preceding month for asthma symptoms occurring more than twice per week, nocturnal cough or insomnia caused by dyspnea, need for short-acting β-mimetics more than twice per week, and physical activity limitations due to dyspnea.
5 years
Evaluation how the place of residence influences the incidence and clinical course of the studied diseases
Time Frame: 5 years
Residence classified as urban (>100,000 inhabitants), town (<100,000 inhabitants), or rural area logistical regression
5 years
Assessment of exposure to PM10 dust at the place of residence during the year preceding study inclusion in children from each group
Time Frame: At baseline
Data will be obtained from the Chief Environmental Protection Inspectorate website and will include average, minimum, and maximum monthly and annual concentrations, ANOVA/non-parametric tests
At baseline
Comparison of the normalized difference vegetation index (NDVI) and chlorophyll index (CI) green levels between study groups at baseline
Time Frame: At baseline
At place of residence
At baseline
Comparison of the sputum culture at baseline and at the control visit
Time Frame: 2 years
Comparison of fact of growth and number of CFU with Fisher's exact or χ² test
2 years
Comparison of the baseline sputum culture findings with BALF culture and metagenomic results
Time Frame: 2 years
Comparison of fact of growth and number of CFU with Fisher's exact or χ² test, logistical regression
2 years
Evaluation of the initial Immunoglobulin E (IgE) concentrations and their dynamics of change between groups
Time Frame: 5 years
Using medians with interquartile ranges and compared using the Mann-Whitney U or Kruskal-Wallis tests
5 years
Comparison of the eosinophil concentrations according to disease type and course
Time Frame: 5 years
Using medians with interquartile ranges and compared using the Mann-Whitney U or Kruskal-Wallis tests
5 years
Assessment of the correlation between ICS used without an asthma diagnosis and airway dysbiosis
Time Frame: 2 years
PERMANOVA and logistic regression
2 years
Evaluation of asthma treatment response, exacerbation rates, and need for bronchodilators according to airway metabolome profiles
Time Frame: 5 years
PERMANOVA and logistic regression
5 years
Comparison of the asthma subtypes and evaluate possibilities for developing personalized treatment in selected pediatric groups
Time Frame: 2 years
An attempt to assess the presence and relationship of asthma subtypes in relation to metagenomic and metabolomic findings PERMANOVA and logistic regression
2 years
Identification of the most common pathogens cultured from BALF samples in children with asthma, PBB, chronic cough, and in those taking ICS without an asthma diagnosis
Time Frame: Index hospitalization, immediately after the procedure
descriptive statistics
Index hospitalization, immediately after the procedure
Analysis of the frequency and type of antibiotic therapy in each study group and correlate these findings with the total number of respiratory diseases in individual participants.
Time Frame: 5 years
Cox proportional hazards model
5 years
Evaluation of the recurrence rates of PBB and development of CSLD and BE based on identified airway pathogens
Time Frame: 5 years
Cox proportional hazards model, descriptive statistics
5 years
Assessment of the prevalence of antibiotic-resistant strains among patients with PBB
Time Frame: 5 years
descriptive statistics
5 years
Assessment of the time to PBB development in previously healthy children based on metagenomic and metabolomic findings
Time Frame: 5 years
Cox proportional hazards model
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Collaborators

Medical University of Lodz
Medical University of Bialystok

Investigators

  • Principal Investigator: Wojciech Feleszko, MD, PhD, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

September 25, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/100/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD may be available upon request, by default IPD sharing is not planned.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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