AuthorisedTherapeutic use (Phase IV)Interventional

Assessing the efficacy of Elixirium thymi compositum in the treatment of acute bronchitis in pediatric patients (EXOTIC): A double-blind, randomized, placebo-controlled, phase 4 study

This research study, called EXOTIC, is investigating a syrup called Elixirium thymi compositum. It's for children who have acute bronchitis, a common chest infection that often causes a cough. The study wants to find out if this syrup is effective in making children feel better and reducing their symptoms. Researchers will also check if the syrup is safe and well-tolerated. Some children will get the active syrup, and others will get a placebo (a dummy syrup that looks the same but has no active medicine) to fairly compare the two. This is a common way to test new medicines and ensure any benefits seen are due to the treatment itself.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Semmelweis University

Enrolment target

Start

07 May 2025

Acute bronchitis

What is this study about?

This study is called EXOTIC, and its main goal is to test a medicine called Elixirium thymi compositum. This medicine comes as a syrup and is being looked at for children and young people who have acute bronchitis. Acute bronchitis is a common illness where the tubes leading to your lungs get inflamed, often causing a cough and sometimes other symptoms like a runny nose or sore throat. It usually gets better on its own, but treatments can sometimes help with symptoms.

Researchers want to see how well this syrup works compared to a 'dummy' syrup (placebo). A placebo looks exactly like the real medicine but contains no active ingredients. This is a standard and important part of medical research, as it helps doctors tell if any improvement is truly due to the medicine or just to other factors. The study will carefully measure if the children's bronchitis symptoms get better with the syrup.

This is a 'Phase 4' study, which means the medicine might already be available in some places, but researchers are still gathering more information about how well it works and its safety in a wider group of people in a very controlled way. This helps to build up a full picture of the medicine for doctors and patients.

Key takeaways

The study tests a syrup for children with acute bronchitis.
It compares the new syrup to a dummy treatment (placebo).
Both safety and how well it works are being carefully checked.
Participation helps future children with similar conditions.
You won't know if your child gets the active syrup or placebo.

Who may be eligible?

This study is looking for children and young people of all ages who have acute bronchitis. Acute bronchitis means you have a new chesty cough and possibly other cold-like symptoms, but it's not due to another long-term lung condition.

Both boys and girls are welcome to take part in this research. The medical team will check other health details to make sure the study is right and safe for each child.

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 experiencing acute (new) bronchitis?
Is your child generally healthy apart from the bronchitis?
Are you able to attend study visits as required?
Are you happy for your child to be given either the active syrup or a dummy syrup?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will be given either the Elixirium thymi compositum syrup or the placebo syrup. Neither you nor the study team will know which syrup your child is receiving; this is called 'double-blind' and ensures the results are fair. Your child will need to take the syrup as instructed. The study team will regularly check your child's symptoms using what's called a Bronchitis Severity Score, which helps them track how your child is feeling. They will also ask about any side effects your child experiences to make sure the treatment is safe. The doctor will explain exactly how many visits are needed and for how long the study will last for your child.

Potential risks and benefits

Taking part in a study like this may help us learn more about treating acute bronchitis in children, which could benefit many children in the future. There's a chance your child's symptoms might improve with the study syrup. As with any medicine, there's always a possibility of side effects, even with the placebo. The study team will closely monitor your child for any problems, and you can withdraw your child from the study at any time, for any reason, without it affecting their regular medical care.

Locations (1)

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

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Unverified
Hungary

Common questions

What is acute bronchitis?

It's a common chest infection that causes a cough, often with mucus. It usually gets better on its own.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active ingredients. It helps scientists fairly test medicines.

Will my child definitely get the new syrup?

No, your child will be given either the active syrup or a placebo. It's a bit like flipping a coin for fairness.

What does a 'Phase 4' study mean?

It means the medicine is being studied further to get even more information about how well it works and its safety, even if it might already be available in some places.

What happens if we want to stop participating?

You can withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.