Biomarkers and Respiratory Omics as New CHildren Opportunities - Study of Clinical Outcomes and P… (NCT07232550) | Clinical Trial Compass
RecruitingNot Applicable
Biomarkers and Respiratory Omics as New CHildren Opportunities - Study of Clinical Outcomes and Predictivity Evaluation
Poland160 participantsStarted 2026-03-06
Plain-language 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.
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation on microbiome composition and diversity, cellular composition, and metabolomic profile between study groups
Timeframe: Index hospitalization, immediately after the procedure
2
Correlation of metagenomic and metabolomic findings on subsequent treatment and disease course between groups