Study on Prednisone and Antihistamine for Treating Acute Urticaria in Adults at the Emergency Department

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What is this study about?

This clinical trial is focused on studying the treatment of acute urticaria, a condition characterized by sudden outbreaks of red, itchy welts on the skin, often accompanied by swelling known as angioedema. The study is being conducted in emergency departments and involves adult patients who experience this condition. The treatment being tested includes the use of a medication called prednisone, which is a type of corticosteroid, in combination with an antihistamine. A placebo is also used in the study for comparison purposes.

The purpose of the study is to determine if using just an antihistamine is as effective as using both an antihistamine and a corticosteroid like prednisone in treating acute urticaria. Participants in the study will receive either the combination of medications or the antihistamine alone. The study will monitor the effectiveness of these treatments over a period of time, with a focus on the symptoms experienced by the patients.

Throughout the study, the progress of the participants will be tracked to assess the severity of their urticaria symptoms. This will help researchers understand the best approach to managing acute urticaria in emergency settings, potentially leading to improved treatment strategies for patients experiencing this condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as being over 18 years old, having acute urticaria with angioedema, and providing consent.

Participation requires social security affiliation.

2 initial treatment

The treatment involves the administration of a single antihistamine or a combination of an antihistamine and a corticosteroid.

The corticosteroid used is prednisone, provided as CORTANCYL 20 mg tablets, taken orally.

3 medication administration

The medication is administered as a single dose.

The aim is to assess the effectiveness of the treatment in managing acute urticaria symptoms.

4 monitoring and assessment

The primary measure of success is the 7-Days Urticaria Activity Score (UAS 7) evaluated on day 7.

This score helps determine the effectiveness of the treatment in reducing urticaria symptoms.

5 completion of the trial

The trial is expected to conclude by September 21, 2025.

Participants’ progress and outcomes are documented for analysis.

Who Can Join the Study?

  • Must be an adult, meaning you need to be older than 18 years.
  • Have a condition called acute urticaria, which is a sudden outbreak of red, itchy welts on the skin, along with angioedema, which is swelling under the skin, but without swelling in the throat area (laryngeal edema).
  • Need to give your consent, which means you agree to participate in the study after understanding what it involves.
  • Must be affiliated with social security, meaning you have some form of social health insurance or coverage.

Who Cannot Join the Study?

  • Patients who are not adults cannot participate.
  • Patients who do not have acute urticaria (a sudden outbreak of red, itchy welts on the skin) cannot participate.
  • Patients who are not visiting the emergency department for their condition cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Chlrhj Htasiglyfup Rsptxhlu Dtyhrxhicdbhae Angers France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
21.09.2019

Trial locations

Investigated drugs:

Antihistamine is a medication used to relieve symptoms of allergies, such as itching, swelling, and rashes. In this trial, it is being tested to see if it can effectively treat acute urticaria, which is a sudden outbreak of hives, without the need for additional medications.

Corticosteroid is a type of medication that reduces inflammation and suppresses the immune system. It is often used in combination with antihistamines to treat severe allergic reactions, including acute urticaria. In this trial, it is being used to compare its effectiveness when combined with an antihistamine against using an antihistamine alone.

Acute Urticaria – Acute urticaria is a skin condition characterized by the sudden appearance of red, itchy welts or hives on the skin. These welts can vary in size and may appear and disappear quickly, often within a few hours. The condition is usually triggered by an allergic reaction to certain foods, medications, or other substances. In some cases, the exact cause may not be identified. The hives can be accompanied by swelling, known as angioedema, particularly around the eyes, lips, and throat. While the condition is often uncomfortable, it typically resolves on its own within a few days to weeks.

Trial ID:
2024-515308-38-00
Protocol code:
P160913
NCT ID:
NCT03545464
Trial Phase:
Therapeutic confirmatory (Phase III)

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