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Which inhaler works best for preterm children with lung disease? a study seeks answers

NCT ID NCT06110481

Knowledge-focused Sponsor: Charles University, Czech Republic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study looks at how children born preterm with chronic lung disease respond to different inhaled bronchodilators. Participants will have their lung function tested before and after using three types of inhalers: salbutamol, ipratropium bromide, and a combination of fenoterol with ipratropium bromide. The goal is to see if one drug or combination works better overall, and whether individual children respond differently to each treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inhaled bronchodilators (salbutamol, ipratropium bromide, and a combination of fenoterol with ipratropium bromide)
What this could lead to
If successful, this study could help doctors choose the most effective bronchodilator or combination for children born preterm with chronic lung disease, improving their breathing treatment.
What could go wrong
This is an observational study with a small number of participants, so results may not apply to all children. Individual responses to the drugs may vary, and the study does not test long-term outcomes.

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.

Participants

73 people

The number who actually took part.

Started

Apr 2021

Finished

Dec 2025

Lead sponsor

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.

Who is studied

children born preterm before 35+0 of gestational age (35+0) with chronic lung disease of prematurity with bronchial obstruction, confirmed by spirometry.

Ages

5 to 18 years

Sex

Anyone

Show 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: * 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 Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Bronchial Hyperreactivity bronchopulmonary dysplasia obstructive lung disease reactive airway disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchial hyperreactivity Bronchial obstruction Bronchopulmonary dysplasia Chronic lung disease of newborn Chronic lung disease of prematurity Preterm birth complication Reversible dilatation

Contacts and locations

Locations

  • First faculty of Medicine, Charles university.

    Prague, 128 00, Czechia

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