Can an asthma inhaler drug open narrowed airways in preterm kids?
NCT ID NCT07827859
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Preterm birth often leaves children with lasting airway narrowing that causes breathlessness and limits exercise. Researchers are testing whether inhaled tiotropium, a drug already approved for older children with severe asthma, can improve lung function in preterm-born children and teens aged 6 to 18 with chronic bronchial obstruction. In this phase 4 crossover trial, 50 participants each spend three months on daily tiotropium and three months on standard care without long-term anticholinergic therapy, with the order randomly assigned. The main measure is change in forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) between the two periods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- inhaled tiotropium bromide, a long-acting airway-opening drug
- What this could lead to
- If it works, inhaled tiotropium could become a new treatment option for preterm-born children with chronic airway narrowing, a group that currently has few targeted therapies.
- What could go wrong
- This is a small, single-center phase 4 trial of 50 children, so results may not apply broadly. Tiotropium can cause dry mouth, constipation, or urinary retention, and it may not improve lung function in this specific group.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age between 6 and 18 years. * History of preterm birth (defined as delivery at \< 37 gestational weeks). * Spirometrically proven bronchial obstruction, defined as a z-score of FEV1 and/or \>= 2 other parameters - Forced Vital Capacity (FVC; liters \[L\]), Peak Expiratory Flow (PEF; liters per second \[L/s\]), and Forced Expiratory Flow between 25% and 75% of Forced Vital Capacity (FEF25-75; liters per second \[L/s\]).) below -1.65 SD. * Positive bronchodilatation test, defined as an increase in FEV₁ or FVC of more than 10% of the corresponding GLI-predicted value following administration of ipratropium bromide. Bronchodilator responsiveness will be calculated separately for FEV₁ and FVC as: \[(post-bronchodilator value - pre-bronchodilator value) / predicted value\] × 100. FEV₁ and FVC will be measured in litres (L) after ipratropium administration. * Acceptable spirometry performance in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) 2019 standards. * No long-term inhalation therapy (such as a long-acting beta₂-agonist (LABA) or a combination of an inhaled corticosteroid and a long-acting beta₂-agonist (ICS/LABA)) within the last month prior to study enrollment. Exclusion Criteria: * Other chronic respiratory diseases (e.g., asthma, cystic fibrosis). * Anatomical abnormalities of the respiratory tract or presence of glaucoma. * Congenital malformations of the uropoetic tract or cardiac arrhythmias/congenital heart defects. * Concomitant use of anticholinergic medications for enuresis nocturna. * Pregnancy (mandatory urine screening required for all female participants aged 13 years and older). * Insufficient cooperation or inability to properly perform spirometry maneuvers.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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General University Hospital in Prague, Department of Paediatrics and Inherited Metabolic Disorders (KPDPM)
Prague, 128 08, Czechia
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