Reversibility of Bronchial Obstruction in Children Born Preterm

Last updated: May 19, 2025
Sponsor: Charles University, Czech Republic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bronchiectasis

Lung Disease

Treatment

N/A

Clinical Study ID

NCT06110481
CZ-VFN-PEDMET-BPD-001
  • Ages 5-18
  • All Genders

Study Summary

This observational study aims to compare responses to different, commonly used inhaled bronchodilators in children born preterm with bronchial obstruction at spirometry. All children were diagnosed with Chronic Lung Disease of Immaturity (CLDI).

The main questions are:

  • Is any inhaled bronchodilator or their combination generally superior in children with CLDI when assessing the reversibility of bronchial obstruction?

  • Is there an individual difference in the effect of betamimetic, anticholinergic or their combination between children with CLDI?

Participants will:

  • Come to our clinic in a stable state without acute infection and they will be randomly assigned to the first inhaled bronchodilator.

  • They will then perform a spirometry test before and after the inhalation of the drug.

  • This visit will repeat 3 times, each with a different bronchodilator (beta2agonist, anticholinergic and their combination).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • children born preterm /before the 35th week of gestational age (35+0)/

  • all subjects must have chronic lung disease of prematurity with bronchialobstruction, confirmed by spirometry

  • subjects must be able to cooperate well in spirometry

Exclusion

Exclusion Criteria:

  • The presence of another chronic respiratory disease (e.g., cystic fibrosis, primaryciliary dyskinesia, etc.). Asthma bronchiale is not an exclusion criterion, butsubjects with CLDI combined with asthma bronchiale represent a specific subgroup ofsubjects and we perform a standardized therapeutic test with inhaled corticosteroids (ICS) administered for at least 12 weeks via a pressurized aerosol dispenser (pMDI)via an inhaler attachment before enrollement.

  • Insufficient cooperation during spirometry.

Study Design

Total Participants: 80
Study Start date:
April 01, 2021
Estimated Completion Date:
January 01, 2026

Study Description

  1. Outpatient follow-up - Parents are asked to sign the study consent form if the child meets the indication criteria. If the trial subject is not taking inhaled therapy, he/she may immediately continue to Check-up A. If the subject is taking short- or long-acting bronchodilators, these medications must be discontinued before each check-up and at the following intervals:

    • Short-acting β2 agonists (SABA) - 12 hours before the examination

    • Short-acting inhaled cholinergic antagonists (e.g. ipratropium bromide) - 12 hours before the examination

    • Long-acting inhaled betamimetics (long-acting β2 agonists, LABAs) - 48 hours before the examination

    • Long-acting muscarinic antagonists (LAMA) - one week before the examination

  2. Check-up A - Baseline pre-interventional spirometry may be performed if the subject has no evidence of acute respiratory infection or has not had an acute respiratory infection two weeks previously. Otherwise, the examination should be rescheduled. Before baseline spirometry, the child is randomized to a dilatation test with inhaled salbutamol, ipratropium, or a combination of fenoterol/ipratropium. After a defined time interval (15 - 30 minutes), post-interventional spirometry follows.

    The subject is invited to attend Check-up B (which preferably follows 1 to 30 days after Check-up A, but no later than 3 months).

  3. Check-up B - Baseline pre-interventional spirometry may be performed if the subject has no evidence of acute respiratory infection or has not had an acute respiratory infection two weeks previously. Otherwise, Check-up B should be rescheduled. Before baseline spirometry, another inhaled bronchodilator according to the preceding randomisation is applied. After a defined time interval (15 - 30 minutes), post-interventional spirometry follows. Resting spirometry with a dilatation test with another drug, the choice of which is guided by randomization, is performed.

  4. Check-up C - Baseline pre-interventional spirometry may be performed if the subject has no evidence of acute respiratory infection or has not had an acute respiratory infection two weeks previously. Otherwise, Check-up C should be rescheduled. Baseline spirometry with the last bronchodilator not yet used is performed.

Connect with a study center

  • First faculty of Medicine, Charles university.

    Prague, 128 00
    Czechia

    Active - Recruiting

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