Asthma in ChildrenBRONCHOSCOPENCT07232550
Biomarkers and Respiratory Omics as New CHildren Opportunities - Study of Clinical Outcomes and Predictivity Evaluation
An observational study of Asthma in Children and Protracted Bacterial Bronchitis, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Asthma in Children, Protracted Bacterial Bronchitis, Chronic Cough
- What is being tested?
- fiberoptic bronchoscopy, blood sample collection and Respiratory functional tests
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 sitePoland
- Study dates
- 6 Mar 2026to Dec 2035
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Żwirki i Wigury 63A
Warsaw, 02-091
Tomasz Kopiec, MD, +48223179432, tomasz.kopiec@wum.edu.pl
Aleksander Adamiec, MD, +48223179433, aleksander.adamiec@wum.edu.pl
About this study
Official title: 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.
Read the 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.
- Being tested
- fiberoptic bronchoscopy, blood sample collection, Respiratory functional tests, Sputum culture
- Keywords
- PBB, Asthma
- Medical subject headings
- Chronic Cough, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiberoptic bronchoscopyProcedure or surgery
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 collectionProcedure or surgery
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 testsDiagnostic test
At baseline and during each follow-up visit children will perform spirometry, Impulse Oscillometry and Fractional Exhaled Nitric Oxide
Sputum cultureDiagnostic test
At baseline and during first follow-up visit sputum will be collected from each individual for culture
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Children diagnosed with asthma at the baseline Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: fiberoptic bronchoscopy; Procedure: blood sample collection; Diagnostic Test: Respiratory functional tests; Diagnostic Test: Sputum culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 years
Secondary outcomes (17)
Comparison of the previous medical history and demographic characteristics across the study groups
MANOVA, neural networks and logistic regression
Measured: At baseline
Assessment of the degree of asthma control among children diagnosed with asthma according to Global Initiative for Asthma
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.
Measured: 5 years
Evaluation how the place of residence influences the incidence and clinical course of the studied diseases
Residence classified as urban (>100,000 inhabitants), town (<100,000 inhabitants), or rural area logistical regression
Measured: 5 years
Assessment of exposure to PM10 dust at the place of residence during the year preceding study inclusion in children from each group
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
Measured: At baseline
Comparison of the normalized difference vegetation index (NDVI) and chlorophyll index (CI) green levels between study groups at baseline
At place of residence
Measured: At baseline
Comparison of the sputum culture at baseline and at the control visit
Comparison of fact of growth and number of CFU with Fisher's exact or χ² test
Measured: 2 years
Comparison of the baseline sputum culture findings with BALF culture and metagenomic results
Comparison of fact of growth and number of CFU with Fisher's exact or χ² test, logistical regression
Measured: 2 years
Evaluation of the initial Immunoglobulin E (IgE) concentrations and their dynamics of change between groups
Using medians with interquartile ranges and compared using the Mann-Whitney U or Kruskal-Wallis tests
Measured: 5 years
Comparison of the eosinophil concentrations according to disease type and course
Using medians with interquartile ranges and compared using the Mann-Whitney U or Kruskal-Wallis tests
Measured: 5 years
Assessment of the correlation between ICS used without an asthma diagnosis and airway dysbiosis
PERMANOVA and logistic regression
Measured: 2 years
Evaluation of asthma treatment response, exacerbation rates, and need for bronchodilators according to airway metabolome profiles
PERMANOVA and logistic regression
Measured: 5 years
Comparison of the asthma subtypes and evaluate possibilities for developing personalized treatment in selected pediatric groups
An attempt to assess the presence and relationship of asthma subtypes in relation to metagenomic and metabolomic findings PERMANOVA and logistic regression
Measured: 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
descriptive statistics
Measured: 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.
Cox proportional hazards model
Measured: 5 years
Evaluation of the recurrence rates of PBB and development of CSLD and BE based on identified airway pathogens
Cox proportional hazards model, descriptive statistics
Measured: 5 years
Assessment of the prevalence of antibiotic-resistant strains among patients with PBB
descriptive statistics
Measured: 5 years
Assessment of the time to PBB development in previously healthy children based on metagenomic and metabolomic findings
Cox proportional hazards model
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start6 Mar 2026
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Lodz, Medical University of Bialystok
- Responsible party
- Sponsor
- Investigators
- Wojciech Feleszko, MD, PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232550
- Sponsor's protocol ID
- KB/100/2025
- Acronym
- BRONCHOSCOPE
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD may be available upon request, by default IPD sharing is not planned.
Publications
Martin J, Townshend J, Brodlie M. Diagnosis and management of asthma in children. BMJ Paediatr Open. 2022 Apr;6(1):e001277. doi: 10.1136/bmjpo-2021-001277.
PubMed 35648804Thomas R, Marchant JM, Goyal V, Masters IB, Yerkovich ST, Chang AB. Clinical utility of elective paediatric flexible bronchoscopy and impact on the quality of life: protocol for a single-centre, single-blind, randomised controlled trial. BMJ Open Respir Res. 2024 Feb 26;11(1):e001704. doi: 10.1136/bmjresp-2023-001704.
PubMed 38413121Licata MA, Mencarini P, Mastrobattista A, Carli SM, Cerva C, Mosti S, Libertone R, Zolezzi A, Vittozzi P, Nisii C, Mazzarelli A, Cannas A, Navarra A, Ianniello S, Trisolini R, Goletti D, Palmieri F, Gualano G. Clinical Utility of Induced Sputum and Bronchoalveolar Lavage Cultures in Diagnosing Nontuberculous Mycobacterial Pulmonary Disease. Pathogens. 2024 Dec 3;13(12):1064. doi: 10.3390/pathogens13121064.
PubMed 39770324Chang AB, Upham JW, Masters IB, Redding GR, Gibson PG, Marchant JM, Grimwood K. Protracted bacterial bronchitis: The last decade and the road ahead. Pediatr Pulmonol. 2016 Mar;51(3):225-42. doi: 10.1002/ppul.23351. Epub 2015 Dec 4.
PubMed 26636654Gallucci M, Pedretti M, Giannetti A, di Palmo E, Bertelli L, Pession A, Ricci G. When the Cough Does Not Improve: A Review on Protracted Bacterial Bronchitis in Children. Front Pediatr. 2020 Aug 7;8:433. doi: 10.3389/fped.2020.00433. eCollection 2020.
PubMed 32850546Weiss AJ, Liang L, Martin K. Overview of Hospital Stays Among Children and Adolescents, 2019. 2022 Nov 29. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #299. Available from http://www.ncbi.nlm.nih.gov/books/NBK588376/
PubMed 36622925Levy ML, Fleming L, Warner JO, Bush A. Paediatric asthma care in the UK: fragmented and fatally fallible. Br J Gen Pract. 2019 Aug;69(685):405-406. doi: 10.3399/bjgp19X704933. No abstract available.
PubMed 31345822Januska MN, Goldman DL, Webley W, Teague WG, Cohen RT, Bunyavanich S, Vicencio AG. Bronchoscopy in severe childhood asthma: Irresponsible or irreplaceable? Pediatr Pulmonol. 2020 Mar;55(3):795-802. doi: 10.1002/ppul.24569. Epub 2019 Nov 15.
PubMed 31730298Zhang J, Wurzel DF, Perret JL, Lodge CJ, Walters EH, Dharmage SC. Chronic Bronchitis in Children and Adults: Definitions, Pathophysiology, Prevalence, Risk Factors, and Consequences. J Clin Med. 2024 Apr 20;13(8):2413. doi: 10.3390/jcm13082413.
PubMed 38673686Escribano Montaner A, Garcia de Lomas J, Villa Asensi JR, Asensio de la Cruz O, de la Serna Blazquez O, Santiago Burruchaga M, Mondejar Lopez P, Torrent Vernetta A, Feng Y, Van Dyke MK, Reyes J, Garcia-Corbeira P, Talarico CA; EPI-Strep-064 study group. Bacteria from bronchoalveolar lavage fluid from children with suspected chronic lower respiratory tract infection: results from a multi-center, cross-sectional study in Spain. Eur J Pediatr. 2018 Feb;177(2):181-192. doi: 10.1007/s00431-017-3044-3. Epub 2017 Dec 29.
PubMed 29285648Chang AB, Bell SC, Byrnes CA, Dawkins P, Holland AE, Kennedy E, King PT, Laird P, Mooney S, Morgan L, Parsons M, Poot B, Toombs M, Torzillo PJ, Grimwood K. Thoracic Society of Australia and New Zealand (TSANZ) position statement on chronic suppurative lung disease and bronchiectasis in children, adolescents and adults in Australia and New Zealand. Respirology. 2023 Apr;28(4):339-349. doi: 10.1111/resp.14479. Epub 2023 Mar 2.
PubMed 36863703Wiltingh H, Marchant JM, Goyal V. Cough in Protracted Bacterial Bronchitis and Bronchiectasis. J Clin Med. 2024 Jun 4;13(11):3305. doi: 10.3390/jcm13113305.
PubMed 38893016Marsh RL, Smith-Vaughan HC, Chen ACH, Marchant JM, Yerkovich ST, Gibson PG, Pizzutto SJ, Hodge S, Upham JW, Chang AB. Multiple Respiratory Microbiota Profiles Are Associated With Lower Airway Inflammation in Children With Protracted Bacterial Bronchitis. Chest. 2019 Apr;155(4):778-786. doi: 10.1016/j.chest.2019.01.002. Epub 2019 Jan 17.
PubMed 30660785Broderick DTJ, Waite DW, Marsh RL, Camargo CA Jr, Cardenas P, Chang AB, Cookson WOC, Cuthbertson L, Dai W, Everard ML, Gervaix A, Harris JK, Hasegawa K, Hoffman LR, Hong SJ, Josset L, Kelly MS, Kim BS, Kong Y, Li SC, Mansbach JM, Mejias A, O'Toole GA, Paalanen L, Perez-Losada M, Pettigrew MM, Pichon M, Ramilo O, Ruokolainen L, Sakwinska O, Seed PC, van der Gast CJ, Wagner BD, Yi H, Zemanick ET, Zheng Y, Pillarisetti N, Taylor MW. Bacterial Signatures of Paediatric Respiratory Disease: An Individual Participant Data Meta-Analysis. Front Microbiol. 2021 Dec 23;12:711134. doi: 10.3389/fmicb.2021.711134. eCollection 2021.
PubMed 35002989Ausejo M, Saenz A, Pham B, Kellner JD, Johnson DW, Moher D, Klassen TP. The effectiveness of glucocorticoids in treating croup: meta-analysis. BMJ. 1999 Sep 4;319(7210):595-600. doi: 10.1136/bmj.319.7210.595.
PubMed 10473471