RecruitingNAINTERVENTIONAL

Forced Oscillations Technique During a Metacholine Test in Children

This study is exploring a new way to test for asthma in children aged 6 to 16, which could make the process much easier for them. When doctors suspect a child has asthma, they often do a 'methacholine challenge test'. This test involves measuring how much air a child can breathe out forcefully (called FEV1) after they've inhaled a special mist. However, getting clear FEV1 results can be hard for children, as it needs them to cooperate perfectly, which isn't always possible. This study aims to see if a different, simpler breathing measurement technique called 'forced oscillations' can give similar, reliable information about a child's lung function. If successful, this new method could help doctors get accurate asthma diagnoses more comfortably and consistently for children.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Montpellier

Enrolment target

112

Start

07 Sep 2023

Estimated completion

30 Dec 2026

Asthma in Children

What is this study about?

Asthma is a very common long-term lung condition in children, affecting over one in ten kids in France, and similar numbers in other countries like the UK. When a child has symptoms that suggest asthma, doctors often perform a test called a 'methacholine challenge test' to see how sensitive their airways are. This test involves the child breathing in a special mist (methacholine) at increasing strengths, and then measuring how well they can breathe out afterwards.

The standard way to measure breathing during this test is called FEV1, which stands for Forced Expiratory Volume in one second. This requires a child to take a big breath in and then blow out as hard and as fast as they can for at least one second. This can be quite difficult for some children to do correctly, and if they don't do it perfectly, the results might not be accurate. This could lead to a 'false negative', meaning the test says they don't have asthma when they actually do, or sometimes, it's just impossible to get a clear result at all.

This study is looking into a different, potentially simpler way to measure a child's breathing during this test, using something called the 'forced oscillations technique'. The main goal is to see if this new method can predict the changes in FEV1, but with less effort from the child. If successful, it could offer a more reliable and comfortable way for doctors to assess a child's lung function and help diagnose asthma.

Key takeaways

The study aims to find an easier way to test for asthma in children.
It compares a new breathing test method with the standard test.
Participation happens during an already planned clinic visit.
No extra medications are given for the study.
You can withdraw from the study at any time without affecting care.

Who may be eligible?

To join this study, children need to be between 6 and 16 years old. They must already be scheduled to have a methacholine test at the lung function clinic because their doctor suspects they might have asthma. Their current lung function measurements should show they can breathe out at least 60% of the air they normally would.

There are also some important points about medications. Children currently taking inhaled steroid medications for asthma would need to have stopped them for at least three weeks before the study. Also, parents or legal guardians must give their permission, and the child should also agree to take part. The family must also be part of a social security or insurance plan.

Children cannot join if they have used certain quick-acting asthma relievers in the last 6-12 hours, or certain longer-acting asthma medications in the past 36 hours. They also can't have had any chest infections (like colds or flu) in the three weeks before the study. Other reasons a child might not be able to join include having epilepsy that is being treated, already being in another study that might affect their breathing, or if they are unable to understand and agree to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child between 6 and 16 years old?
Is your child already scheduled for a methacholine test?
Has your child stopped inhaled steroid asthma medicines for at least 3 weeks (if applicable)?
Has your child NOT had a cold or chest infection in the last 3 weeks?
Has your child NOT used certain quick-acting asthma relievers in the specific timeframes mentioned?
Are you and your child willing to agree to participate?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will still have their planned methacholine challenge test as usual. The main difference is that during this test, a special device using the 'forced oscillations technique' will also be used to measure their breathing. This measurement is usually much easier for children, as it only requires them to breathe normally into the device, rather than performing strong, forced breaths.

There are no extra study visits beyond the pulmonary function test appointment you already have scheduled. No additional medications will be given as part of this study, and your child will not need any extra follow-up appointments related to the study. The participation will take place during their single, existing clinic appointment. The total duration of their involvement in the study will be limited to this one visit.

Potential risks and benefits

Taking part in this study may not offer direct personal benefits to your child, as the main goal is to improve future asthma testing methods. However, by participating, your child helps researchers learn more about easier ways to diagnose asthma, which could benefit many other children in the future. The risks involved are minimal, as your child will be undergoing the standard methacholine test regardless of whether they participate in the study. The added 'forced oscillations' measurement is non-invasive and generally well-tolerated. You and your child have the right to withdraw from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

CHU de Montpellier
Verified postcode
Montpellier, France· Recruiting

Common questions

What is the methacholine test?

It's a test where a child breathes in increasing amounts of a mist to see if their airways tighten up, which can suggest asthma. It helps doctors decide if asthma is likely.

Why is this new method being studied?

The current methacholine test needs children to blow out very strongly, which can be difficult. This study hopes to find an easier, more reliable way to measure breathing for asthma diagnosis using a simpler 'forced oscillations' technique.

Will my child get any extra medication?

No, this study does not involve giving your child any extra medications. They will only continue with or suspend their usual asthma medications as advised by their own doctor for the methacholine test.

How long will participation take?

Your child's participation will only happen during their single, already scheduled clinic appointment for the methacholine test. There are no extra visits or follow-ups required for the study.

Can we change our mind about participating?

Yes, absolutely. You and your child can decide to withdraw from the study at any time, for any reason, without it affecting your child's medical care.

How to find out more

Stefan MATECKI, MD

stephan.matecki@umontpellier.fr +33 4 67 33 59 12 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.