AuthorisedTherapeutic use (Phase IV)Interventional

Inhaled corticosteroids in young children with episodic wheezing: a multicenter cluster RCT

This research is looking at children who sometimes have wheezing, which can make it hard to breathe. Doctors want to see if using certain inhaler medicines, like 'steroid' inhalers (Beclometasone, Fluticasone, Budesonide) or a 'reliever' inhaler (Salbutamol), can help these children feel better. These are all medicines that doctors already prescribe. The main goal is to find the best way to control their wheezing symptoms so they can play and learn without getting out of breath. This study aims to make sure children get the right treatment to manage their wheezing episodes effectively and improve their quality of life.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

285

Start

09 Oct 2025

Episodic expiratory wheezing

What is this study about?

This study is all about helping young children who experience something called 'episodic wheezing'. This means they sometimes have a whistling or squeaky sound when they breathe out, which can be worrying for parents. These wheezing episodes often happen during colds or other infections, and they can make it difficult for children to breathe properly. The doctors and researchers involved in this study want to find the best way to help these children when they have these wheezing spells.

They are looking at different types of inhalers that are already used by doctors. Some of these are called 'steroid' inhalers, which help to calm down the airways in the lungs and reduce swelling. Examples include Beclometasone, Fluticasone, and Budesonide. Another type of inhaler they are looking at is Salbutamol, which is often called a 'reliever' inhaler because it quickly opens up the airways during a wheezing episode, making it easier to breathe.

The main aim of this study is to see which of these medicines, or combinations of them, works best to control a child's wheezing symptoms. It's like trying different keys to find the one that opens the door most smoothly. By understanding this better, doctors can give clearer advice and help more children breathe easier when they have these wheezy episodes. This is important because good breathing helps children feel better, sleep better, and enjoy their everyday activities without discomfort.

Key takeaways

The study helps children who get wheezy sometimes.
It tests different inhaler medicines already in use.
The goal is to find the best way to control wheezing symptoms.
This research aims to improve children's breathing and well-being.
Participation involves using inhalers and regular check-ups.

Who may be eligible?

This study is looking for young children who sometimes experience wheezing. This means children who might get a whistling sound when they breathe out, especially when they have a cold or other illness. The researchers are interested in children of any age range who experience these types of breathing difficulties.

Both boys and girls are welcome to take part in this study. The most important thing is that the child experiences these 'episodic wheezing' symptoms. If you're unsure if your child's symptoms fit this description, it's always best to talk to your child's doctor.

Quick self-check

Is my child under 18 years old?
Does my child sometimes make a whistling sound when they breathe out?
Do these wheezing episodes often happen during colds or infections?
Is my child currently under the care of a doctor for their breathing?
Am I able to attend regular appointments for my child?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child takes part in this study, it would involve them using different types of inhalers as guided by the study team. You would likely have several visits to a clinic or hospital over a period of time so doctors can monitor your child's wheezing and how they are responding to the treatments. These visits might include checking your child's breathing, asking you questions about their symptoms, and sometimes simple tests. The study will continue as long as necessary to understand the effectiveness of the treatments, which could be for several months or longer. You'll be given clear instructions on how to use the inhalers and what to look out for. All assessments and medications related to the study will be provided by the research team.

Potential risks and benefits

Taking part in this study could offer some potential benefits, as your child would receive careful monitoring and access to treatments that might help control their wheezing. However, as with any medication, there can be potential risks or side effects, although these are usually mild and temporary for the inhalers being tested. You would be given full information about any potential side effects. There is also the possibility that the treatment might not work as well for your child as hoped. Remember, you can choose to withdraw your child from the study at any time, for any reason, without it affecting their regular medical care.

Locations (1)

—
Netherlands

Common questions

What is 'episodic wheezing'?

It's when a child sometimes makes a whistling sound when they breathe out, especially during colds or infections.

Are the medicines in this study new?

No, all the inhaler medicines being studied are already used by doctors to treat breathing problems.

Will my child get a placebo (dummy medicine)?

This study is comparing existing medicines, so your child would receive an active treatment.

How long would my child need to be in the study?

The study's duration would depend on the specific plan, but it usually involves regular check-ups over a period of months.

What if my child feels worse during the study?

You should always contact the study team or your child's doctor immediately if you have any concerns about their health.