Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

COURAGE - Corticosteroid in acute urticaria in emergency department

This study, called COURAGE, is for adults over 18 who visit A&E because they've suddenly developed an itchy skin rash known as urticaria, or hives. Researchers want to compare a common steroid medicine (similar to Prednisolone, often used to reduce inflammation) with a placebo (a dummy pill that looks the same but has no active medicine). The main goal is to find out if the steroid is better at clearing up the rash and reducing symptoms after one week. This type of study is an important final step to confirm if a treatment works and is safe for wider use. It's designed to help doctors understand the best way to treat acute urticaria.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

240

Start

13 Aug 2024

Adults patients with isolated acute urticaria presenting to the emergency department

What is this study about?

Imagine you suddenly get an itchy, red, and sometimes swollen skin rash all over your body – that's urticaria, also known as hives. It can be quite uncomfortable and worrying, especially when it appears out of nowhere, which is why some people end up in A&E.

This study, called COURAGE, is specifically for adults who experience this sudden type of urticaria (acute urticaria) and seek help at the hospital's emergency department. Doctors are trying to find the best way to help people recover quickly from this type of rash. They are comparing a common steroid medication with a placebo (a dummy pill). Steroids are often used to calm down inflammation and allergic reactions in the body.

The main question the researchers want to answer is whether taking this steroid medication works better than a dummy pill to make the urticaria go away or get much better within seven days. The information from this study will help healthcare professionals understand if this specific steroid treatment is a good option for people with acute urticaria in an A&E setting, ultimately aiming to improve how this common condition is treated for future patients.

Key takeaways

Study for adults with sudden itchy skin rashes (urticaria) seen in A&E.
Compares a steroid medicine to a dummy pill (placebo).
Aims to see if the steroid helps clear the rash in 7 days.
Participation involves taking medication and symptom tracking.
Helps improve future treatments for acute urticaria.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adult patients, meaning anyone 18 years old or older, who come to the emergency department (A&E) because they have suddenly developed an itchy skin rash known as acute urticaria, or hives. The main point is that this rash should be the only significant health problem you're dealing with at that moment in A&E.

Both men and women can potentially take part. The study needs people who are experiencing this specific type of rash so that researchers can accurately test the medication. Your doctor will carefully check if you meet all the necessary requirements to ensure the study is safe and effective for you.

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 18 years old or older?
Are you visiting A&E today for a sudden, itchy skin rash (hives)?
Is this rash the main health problem you're seeking help for right now?
Are you able to agree to take part and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given either the steroid medication (CORTANCYL 20 mg) or a placebo (a dummy pill) for a short period. You wouldn't know which one you received, nor would your doctors, to ensure the results are fair. The main assessment would involve tracking your urticaria symptoms and how active your rash is over 7 days, likely using a simple scoring system called the Urticaria Activity Score (UAS 7). There might be follow-up phone calls or visits to check on your progress and any side effects. The total duration of your active involvement would likely be around one week, followed by any necessary checks. You would be fully informed about all appointments and what's expected before you agree to participate.

Potential risks and benefits

Taking part in a study like this could potentially mean your urticaria improves faster if you receive the active steroid medication. However, there's also a chance you might receive the placebo, which means your rash would be treated as usual by your doctors. As with any medication, there's always a possibility of side effects from the steroid, though they are usually mild and temporary for short courses. Your doctors will explain all known risks. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
France

Common questions

What is 'acute urticaria'?

It's a sudden outbreak of itchy red welts (hives) on the skin, often appearing quickly and lasting for less than six weeks.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medication but doesn't contain any active drug. It helps researchers see if the real medication works better than no treatment at all.

Will I know if I'm getting the real medication or the placebo?

No, neither you nor your study doctors will know, this is called 'blinding'. This helps make sure the study results are fair and unbiased.

What does a 'Phase III' study mean?

Phase III means the treatment has already been tested in earlier stages and appears safe. This phase confirms if it works well and is safe for a larger group of people, before it might become a standard treatment.

How long will I be involved in the study?

The main part of the study involves tracking your symptoms for 7 days, with any follow-up checks after that time.