Corticosteroid in acute urticaria in emergency department

Phase 3

Active, not recruiting

• Conditions: Adults patients with isolated acute urticaria presenting to the emergency department

• Registration Number: 2024-515308-38-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris

Brief Summary

To demonstrate the non-inferiority of the efficacy of a single antihistamine in comparaison with an association of antihistamine and corticosteroid in the treatment of acute urticaria in emergency departments

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

Age > 18 years

Acute urticaria with angioedema without laryngeal edema

Obtain patient’s consent

Social security affiliation

Exclusion Criteria

Pregnancy or breastfeeding

Atopic dermatitis

Eczema

Bullous pemphigoid

Acute exanthematous pustulosis

Diabetes mellitus

Gastrointestinal ulcer

Refusal to participate

Known allergy to the study drugs or formulation ingredients

Hypersensitivity to lactose

Known Renal failure defined by creatinine clearance < 10 mL/min or cardiac failure defined by ejection fraction < 40%

Acute hives with anaphylaxis

Hypersensitivity to active substance, to cetirizine, to hydroxyzine and to pipérazine and excipients

Contre-indication to corticotherapy: o Any live vaccine o Psychotic states still uncontrolled by treatment limiting the participant's compliance with the research o Some viruses in evolution (including hepatitis, herpes, chicken pox, shingles). o Any infectious condition

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, ciclosporine A

Chronic urticaria before acute urticaria diagnosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
7-Days Urticaria Activity Score (UAS 7) at day 7		7-Days Urticaria Activity Score (UAS 7) at day 7

Trial Locations

Locations (5)

Hospices Civils De Lyon; 🇫🇷 Lyon Cedex 03, France

Centre Hospitalier Universitaire De Bordeaux; 🇫🇷 Bordeaux, France

Centre Hospitalier Universitaire D'Angers; 🇫🇷 Angers, France

Assistance Publique Hopitaux De Paris; 🇫🇷 Paris Cedex 18, France

Centre Hospitalier Universitaire Grenoble Alpes; 🇫🇷 Grenoble Cedex 9, France

Hospices Civils De Lyon

🇫🇷Lyon Cedex 03, France

Marion DOUPLAT

Site contact

0478865711

marion.douplat@chu-lyon.fr

Karim TAZAROURTE

Site contact

0472110041

karim.tazarourte@chu-lyon.fr