COrticosteroids in acUte uRticAria in emerGency dEpartment

Phase 1

• Conditions: Adults patients with isolated acute urticaria presenting to the emergency department; MedDRA version: 20.0Level: LLTClassification code 10001106Term: Acute urticariaSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-002308-15-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 192
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

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
Hypersensitivity to lactose
Known Renal failure defined by creatinine clearance < 10 mL/min or cardiac failure defined by ejection fraction < 40%.
Hypersensitivity to active substance, to cetirizine, to hydroxyzine and to pipérazine and excipients
Contre-indication to corticotherapy:
oAny live vaccine
oPsychotic states still uncontrolled by treatment limiting the participant's compliance with the research
oSome viruses in evolution (including hepatitis, herpes, chicken pox, shingles).
oAny infectious condition

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: To compare the number of urticaria recurrences at day 7, to compare the number of transition to chronic urticaria, to compare the morbidity, to compare the number of patients with angioedema, to compare the quality of life;Primary end point(s): 7-Days Urticaria Activity Score (UAS 7);Timepoint(s) of evaluation of this end point: at day 7

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): recurrences of heaves and/or itch at day 7, occurrence of spontaneous wheals and/or itch for > 6 weeks, the reduction of morbidity is assess by new emergency visits for acute urticaria recurrences, Dermatology Life Quality Index (DLQI), Cu-Q2oL;Timepoint(s) of evaluation of this end point: at day 7, and after 6 weeks