Bronchopulmonary DysplasiaNCT06110481
Reversibility of Bronchial Obstruction in Children Born Preterm
An observational study of Bronchopulmonary Dysplasia and Chronic Lung Disease of Prematurity, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Chronic Lung Disease of Newborn
- How many people
- 73 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2021to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 18 years
- All sexes
- Child, Adult
Study population: children born preterm before 35+0 of gestational age (35+0) with chronic lung disease of prematurity with bronchial obstruction, confirmed by spirometry.
Who may be able to join
- children born preterm /before the 35th week of gestational age (35+0)/
- all subjects must have chronic lung disease of prematurity with bronchial obstruction, confirmed by spirometry
- subjects must be able to cooperate well in spirometry
Who cannot join
- The presence of another chronic respiratory disease (e.g., cystic fibrosis, primary ciliary dyskinesia, etc.). Asthma bronchiale is not an exclusion criterion, but subjects with CLDI combined with asthma bronchiale represent a specific subgroup of subjects 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bronchodilator Response To Inhaled Beta-2 Agonist and Anticholinergic Drugs in Children Born Preterm
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:
Read more
- 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).
Read the detailed description
- 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
- 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).
- 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.
- 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.
- Conditions
- Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Chronic Lung Disease of Newborn, Preterm Birth Complication, Bronchial Hyperreactivity, Bronchial Obstruction
- Medical subject headings
- Bronchopulmonary Dysplasia, Bronchial Hyperreactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of spirometric parameters of bronchial obstruction in children born preterm to inhaled salbutamol, ipratropium bromide and combination of fenoterol with ipratropium bromide
Spirometric parameters of bronchial obstruction before and after inhaled application of bronchodilator during check-up. Three types of bronchodilators (salbutamol, ipratropium bromide and combined inhaler of fenoterol with ipratropium bromide) at three different check-ups will be tested with the order selected by randomisation.
Z-score of baseline (pre-interventional) spirometric expiratory flow parameters (MMEF (l/s), MEF75 (l/s), MEF50 (l/s), MEF25 (l/s) retrieved from flow-volume curve compared to post-interventional z- scores of MMEF (l/s), MEF75 (l/s), MEF50 (l/s), MEF25 (l/s) values measured after a predefined time interval specific to bronchodilator (15-30 minutes). Four standardised doses of bronchodilators will be administered with metered-dose inhaler by spacer without a mask.
Measured: baseline and post-interventional spirometry after 15-30 minutes (interval specific to bronchodilator) during three check-ups with min. time interval between check-ups 24 hours and max. 30 days
Change of spirometric parameters of lung volume in children born preterm to inhaled salbutamol, ipratropium bromide and combination of fenoterol with ipratropium bromide
Spirometric parameters of lung volume before and after inhaled application of bronchodilator during check-up. Three types of bronchodilators (salbutamol, ipratropium bromide and combined inhaler of fenoterol with ipratropium bromide) at three different check-ups will be tested with the order selected by randomisation.
Z-score of baseline (pre-interventional) spirometric volume parameters FEV 0.5 (ml), FVC (ml) retrieved from flow-volume curve compared to post-interventional z- scores of FEV 0.5 (l), FVC (l) values measured after a predefined time interval specific to bronchodilator (15-30 minutes). Four standardised doses of bronchodilators will be administered with metered-dose inhaler by spacer without a mask.
Measured: baseline and post-interventional spirometry after 15-30 minutes (interval specific to bronchodilator) during three check-ups with min. time interval between check-ups 24 hours and max. 30 days
Change of area under the flow-volume spirometric curve in children born preterm to inhaled salbutamol, ipratropium bromide and combination of fenoterol with ipratropium bromide
Complex spirometric parameter of area under the curve before and after inhaled application of bronchodilator during check-up. Three types of bronchodilators (salbutamol, ipratropium bromide and combined inhaler of fenoterol with ipratropium bromide) at three different check-ups will be tested with the order selected by randomisation.
Z-score of baseline (pre-interventional) Aex (l*l/s) retrieved from flow-volume curve compared to post-interventional z- scores of Aex (l*l/s) values measured after a predefined time interval specific to bronchodilator (15-30 minutes). Four standardised doses of bronchodilators will be administered with metered-dose inhaler by spacer without a mask.
Measured: baseline and post-interventional spirometry after 15-30 minutes (interval specific to bronchodilator) during three check-ups with min. time interval between check-ups 24 hours and max. 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Apr 2021
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jana Tuková, Charles University, Czech Republic
- Investigators
- Jana Tukova, MD,PhD, Principal investigator, Charles University, Czech Republic First Faculty of Medicine, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110481
- Sponsor's protocol ID
- CZ-VFN-PEDMET-BPD-001
- Status last verified
- Jul 2026
- First submitted
- 11 Sep 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchodilator Response To Inhaled Beta-2 Agonist and Anticholinergic Drugs in Children Born Preterm
- ClinicalTrials.gov ID
- NCT06110481
- Acronym / sponsor ID
- CZ-VFN-PEDMET-BPD-001
- Conditions
- Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Chronic Lung Disease of Newborn, Preterm Birth Complication, Bronchial Hyperreactivity, Bronchial Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
- 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
- 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).
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- children born preterm before 35+0 of gestational age (35+0) with chronic lung disease of prematurity with bronchial obstruction, confirmed by spirometry.
Key inclusion criteria (3 listed)
- children born preterm /before the 35th week of gestational age (35+0)/
- all subjects must have chronic lung disease of prematurity with bronchial obstruction, confirmed by spirometry
- subjects must be able to cooperate well in spirometry
Key exclusion criteria (2 listed)
- The presence of another chronic respiratory disease (e.g., cystic fibrosis, primary ciliary dyskinesia, etc.). Asthma bronchiale is not an exclusion criterion, but subjects with CLDI combined with asthma bronchiale represent a specific subgroup of subjects 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of spirometric parameters of bronchial obstruction in children born preterm to inhaled salbutamol, ipratropium bromide and combination of fenoterol with ipratropium bromide
Time frame: baseline and post-interventional spirometry after 15-30 minutes (interval specific to bronchodilator) during three check-ups with min. time interval between check-ups 24 hours and max. 30 days
Spirometric parameters of bronchial obstruction before and after inhaled application of bronchodilator during check-up. Three types of bronchodilators (salbutamol, ipratropium bromide and combined inhaler of fenoterol with ipratropium bromide) at three different check-ups will be tested with the order selected by randomisation. Z-score of baseline (pre-interventional) spirometric expiratory flow parameters (MMEF (l/s), MEF75 (l/s), MEF50 (l/s), MEF25 (l/s) retrieved from flow-volume curve compared to post-interventional z- scores of MMEF (l/s), MEF75 (l/s), MEF50 (l/s), MEF25 (l/s) values measured after a predefined time interval specific to bronchodilator (15-30 minutes). Four standardised doses of bronchodilators will be administered with metered-dose inhaler by spacer without a mask.
Change of spirometric parameters of lung volume in children born preterm to inhaled salbutamol, ipratropium bromide and combination of fenoterol with ipratropium bromide
Time frame: baseline and post-interventional spirometry after 15-30 minutes (interval specific to bronchodilator) during three check-ups with min. time interval between check-ups 24 hours and max. 30 days
Spirometric parameters of lung volume before and after inhaled application of bronchodilator during check-up. Three types of bronchodilators (salbutamol, ipratropium bromide and combined inhaler of fenoterol with ipratropium bromide) at three different check-ups will be tested with the order selected by randomisation. Z-score of baseline (pre-interventional) spirometric volume parameters FEV 0.5 (ml), FVC (ml) retrieved from flow-volume curve compared to post-interventional z- scores of FEV 0.5 (l), FVC (l) values measured after a predefined time interval specific to bronchodilator (15-30 minutes). Four standardised doses of bronchodilators will be administered with metered-dose inhaler by spacer without a mask.
Change of area under the flow-volume spirometric curve in children born preterm to inhaled salbutamol, ipratropium bromide and combination of fenoterol with ipratropium bromide
Time frame: baseline and post-interventional spirometry after 15-30 minutes (interval specific to bronchodilator) during three check-ups with min. time interval between check-ups 24 hours and max. 30 days
Complex spirometric parameter of area under the curve before and after inhaled application of bronchodilator during check-up. Three types of bronchodilators (salbutamol, ipratropium bromide and combined inhaler of fenoterol with ipratropium bromide) at three different check-ups will be tested with the order selected by randomisation. Z-score of baseline (pre-interventional) Aex (l*l/s) retrieved from flow-volume curve compared to post-interventional z- scores of Aex (l*l/s) values measured after a predefined time interval specific to bronchodilator (15-30 minutes). Four standardised doses of bronchodilators will be administered with metered-dose inhaler by spacer without a mask.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jana Tukova, MD,PhD principal investigator
Charles University, Czech Republic First Faculty of Medicine, Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia and Chronic Lung Disease of Prematurity, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of spirometric parameters of bronchial obstruction in children born preterm to inhaled salbutamol, ipratropium bromide and combination of fenoterol with ipratropium bromide (time frame: baseline and post-interventional spirometry after 15-30 minutes (interval specific to bronchodilator) during three check-ups with min. time interval between check-ups 24 hours and max. 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.