RecruitingPHASE2INTERVENTIONAL

NeSST2: The Development of a Noninvasive Short Synacthen Test

This study is researching a new, more comfortable way to check if children's bodies are making enough natural stress hormones. Some children, especially those using inhaled steroids for asthma, might not produce enough of these hormones, a condition called adrenal suppression, which can be serious. Currently, checking this involves needles and multiple blood samples, which can be unpleasant for children. This study aims to develop a new test using a nasal spray and saliva samples instead. This easier test will help doctors understand better which children with asthma are at risk and when to check their hormone levels, ultimately making care better and less stressful for young patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Sheffield Children's NHS Foundation Trust

Enrolment target

Start

12 Oct 2012

Estimated completion

01 Dec 2025

Adrenal Suppression

What is this study about?

You might be wondering why doctors are looking into this topic. It's because some children who use inhaled steroids for asthma might find that their bodies don't make enough of a natural stress hormone called cortisol. Cortisol is really important – it helps your body cope with stress, like when you're ill or injured. If your body can't produce enough cortisol, especially during times of sickness, it can lead to serious health problems. Some tragic cases have shown that this can happen, even though it was once thought inhaled steroids wouldn't affect the body that much.

Because of these concerns, doctors now try to check children on high doses of inhaled steroids. The current way to check is called the Short Synacthen Test (SST). This test involves giving an injection of a medicine called Synacthen into a vein, and then taking several blood samples to see how much cortisol the body produces. As you can imagine, having needles and blood tests can be quite upsetting and uncomfortable for children, and it takes a lot of time. This study is trying to make this test much easier and less scary.

The main goal of this research is to create a new version of the SST that doesn't involve needles. Instead of an injection, the Synacthen would be given as a nasal spray, and researchers would collect saliva samples to measure cortisol. This new 'nasal Synacthen test' would be much simpler and more comfortable for children. If successful, it would allow doctors to safely check more children, help them understand who is most at risk of adrenal suppression, and ultimately improve how we care for children with asthma.

Key takeaways

This study develops a new, needle-free test for adrenal suppression in children.
Adrenal suppression means the body doesn't make enough natural stress hormones.
The new test uses a nasal spray and saliva, aiming for comfort.
It could help identify children at risk, especially those with asthma on inhaled steroids.
The research involves healthy adults and children, and later children with asthma.

Who may be eligible?

This study is looking for different groups of people at different stages. Primarily, it needs healthy adult men aged 18 to 64 for the initial stages of testing the nasal spray. Later, the study will involve healthy children between 2 and 15 years old for further testing.

The final stage will involve children with asthma, aged 6 months to 15 years, who are currently using inhaled steroid medicines. For all participants, there are specific health conditions or medications that would prevent them from taking part. For example, you can't join if you have a history of certain hormone disorders, severe allergies, or if you've recently used other steroid medicines. There are also specific rules about not being a smoker or having a recent cold.

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.

Are you a healthy adult man aged 18-64?
Is your child a healthy child aged 2-15?
Is your child between 6 months and 15 years old, has asthma, and uses inhaled steroids?
Do you or your child have any serious past or present hormone problems?
Have you or your child had a severe allergic reaction to similar medicines before?
Are you or your child currently taking any other medications, especially steroids?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve different things depending on which stage you or your child are in. For adults and healthy children, it would likely mean visiting the research facility multiple times. During these visits, you would receive the Synacthen spray in your nose, and researchers would collect saliva samples at different times to measure hormone levels. Some stages also involve an intravenous (IV) injection of Synacthen for comparison, and a few blood samples.

For children with asthma, the process would be similar, focusing on the nasal spray and saliva samples. The researchers will be looking closely at how the nasal spray works in children. The total duration and number of visits would depend on your specific group, but it could involve around 40 visits for certain stages in children. The team will explain exactly what's involved and how long each visit might take.

Potential risks and benefits

The potential benefit of taking part in this study is contributing to the development of a much easier and more comfortable test for children who might be at risk of adrenal suppression. This could lead to better and less stressful healthcare for many children in the future. Potential risks are generally low, as the key medicine being tested, Synacthen, is already widely used. However, as with any medical procedure, there could be side effects from the nasal spray or blood tests. You will be fully informed of all known side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without affecting your or your child's medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Sheffield Children's NHS Foundation Trust
Verified postcode
Sheffield, United Kingdom· Recruiting

Common questions

What is 'adrenal suppression'?

It's when your body doesn't produce enough of its natural stress hormone, cortisol, especially when you're sick or stressed. This can be serious.

Why is this new test needed?

The current test for adrenal suppression involves needles and blood samples, which can be scary and uncomfortable for children. This new test aims to use a nasal spray and saliva instead, making it much easier.

Will my child get a needle if they join?

The main goal is to avoid needles, using a nasal spray and saliva for the new test. However, some stages of the study, especially for comparison, might involve a small number of blood samples or an IV injection. The study team will explain this clearly.

Who is at risk of adrenal suppression?

Some children who use inhaled steroid medicines for asthma might be at risk. This study wants to help identify who these children are.

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

The time varies depending on the stage of the study your child takes part in. Some parts of the study might involve around 40 visits. The research team will give you a detailed schedule.

How to find out more

Meena Balasubramanian

meena.balasubramanian@nhs.net Official trial record

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