Biomarkers and Respiratory Omics in Children: Predicting Disease Course

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational cohort study will analyze bronchoalveolar lavage, mucosal biopsies, and blood samples to explore microbiome, cellular makeup, and metabolomic profiles in children with asthma, protracted bacterial bronchitis, or chronic cough. Participants undergo fiberoptic bronchoscopy during clinically indicated procedures, with follow-up over five years including non-invasive assessments and repeated respiratory tests. The goal is to identify phenotypes and risk factors that may inform treatment decisions and disease progression. Enrollment targets 160 participants across the Medical University of Warsaw and Medical University of Lodz, with data linkage to clinical history and treatment patterns.

Why it matters

Who can join: the full rules

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

Where it's running

• Żwirki i Wigury 63A
  Warsaw, Poland Recruiting

Study contacts

• Principal investigator: Wojciech Feleszko, MD, PhD — Medical University of Warsaw
• Study coordinator: Tomasz Kopiec, MD
• Email: tomasz.kopiec@wum.edu.pl
• Phone: +48505300599

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.