COrticosteroids in acUte uRticAria in emerGency dEpartment

• Status: Recruiting
• Trial end date: 2022-03-21
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Cetirizine; Levocetirizine; Prednisone

Criteria

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, ciclosporine 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