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ER hives study: do steroids really help?

NCT ID NCT03545464

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether giving a steroid (cortancyl) along with an antihistamine (levocetirizine) is better than the antihistamine alone for treating sudden hives in the emergency department. 137 adults with acute urticaria (with or without mild angioedema) were enrolled. The main goal was to see if the antihistamine alone was not worse than the combination at controlling hives and itching over 7 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Corticosteroid (prednisone) and antihistamine (levocetirizine)
What this could lead to
If successful, this could show that antihistamines alone are enough for acute hives, avoiding unnecessary steroid use.
What could go wrong
This is a completed Phase 3 trial with only 137 participants, so results may not apply to everyone. The study focused on non-inferiority, not superiority, so it may not show a clear benefit of one approach over the other.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

137 people

The number who actually took part.

Started

Sep 2019

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age \> 18 years * Isolated acute urticaria (acute hives): spontaneous urticaria, inducible urticaria * Acute urticaria with angioedema without laryngeal edema * Obtain patient's consent * Social security affiliation Exclusion Criteria: * Pregnancy or breastfeeding * Acute hives with anaphylaxis * Bradykinin angioedema * Angioedema without urticaria (hives) * Laryngeal edema with urticaria (hives) * Corticosteroid administration in the previous 5 days visiting the emergency department * Antihistamines greater than 1 tablet per day in the previous 5 days visiting the ED * Other treatment for urticaria : omalizumab, montelukast, ciclosporin A * Chronic urticaria before acute urticaria diagnosis * Atopic dermatitis * Eczema * Bullous pemphigoid * Acute exanthematous pustulosis * Diabetes mellitus * Gastrointestinal ulcer * Refusal to participate * Known allergy to the study drugs or formulation ingredients * Known Renal failure defined by creatinine clearance \< 10 mL/min or cardiac failure defined by ejection fraction \< 40%. * Corticoid use in 5 days prior to randomisation * Contra-indication to corticotherapy: * Any live vaccine * Psychotic states still uncontrolled by treatment limiting the participant's compliance with the research

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Conditions

The condition(s) this trial relates to.

angioedema urticaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Angiœdema Urticaria

Contacts and locations

Locations

  • Hospital Louis MOURIER

    Colombes, Île-de-France Region, 92700, France

More trials for these conditions

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