Actively Recruiting
Bronchodilator Response to Inhaled Beta-2 Agonist and Anticholinergic Drugs in Children Born Preterm
Led by Charles University, Czech Republic · Updated on 2025-05-22
80
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare how children born preterm with chronic lung disease of prematurity (CLDI) respond to different commonly used inhaled bronchodilators. It focuses on assessing the reversibility of bronchial obstruction in these children and whether any bronchodilator or their combination works better generally or for individual children. The study includes children diagnosed with bronchial obstruction using spirometry and born before the 35th week of gestation. Participants will attend three clinic visits where they will be randomly assigned to inhale one of three bronchodilator treatments: a beta2 agonist (salbutamol), an anticholinergic (ipratropium), or a combination of fenoterol and ipratropium. Before and after inhalation, spirometry tests will be performed to measure lung function. If participants are currently using inhaled bronchodilators, they must stop these medications for specified periods before each visit. The visits are spaced by at least 24 hours and up to 30 days. Throughout the study, children will undergo baseline and post-interventional spirometry to assess changes in bronchial obstruction, lung volume, and flow-volume curve area. Researchers will monitor the response to each bronchodilator across the three check-ups. Parents provide consent, and children must be able to cooperate with spirometry. The study involves outpatient visits without acute respiratory infection and aims to measure the effects of inhaled bronchodilators on lung function over time.
CONDITIONS
Brief Title
Reversibility of Bronchial Obstruction in Children Born Preterm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children born preterm before the 35th week of gestational age (35+0)
- Diagnosed with chronic lung disease of prematurity with bronchial obstruction confirmed by spirometry
- Ability to cooperate well during spirometry tests
You will not qualify if you...
- Presence of other chronic respiratory diseases such as cystic fibrosis or primary ciliary dyskinesia
- Insufficient cooperation during spirometry
- Use of inhaled corticosteroids for at least 12 weeks if diagnosed with asthma bronchiale combined with CLDI before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 months
Participants undergo a series of three check-ups involving baseline and post-interventional spirometry tests after inhalation of different bronchodilator drugs to assess bronchial obstruction reversibility.
3 visits (Check-up A, B, and C)
Trial Site Locations
Total: 1 location
1
First faculty of Medicine, Charles university.
Prague, Czechia, 128 00
Actively Recruiting
Research Team
J
Jana Tukova, MD, PhD
Y
Yotam Ophir, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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