COrticosteroids in acUte uRticAria in emerGency dEpartment (COURAGE)

Assistance Publique - Hôpitaux de Paris

Status and phase: Active, not recruiting; Phase 3

Conditions: Angiœdema; Urticaria

Treatments: Drug: Levocetirizine Oral Tablet; Drug: Cortancyl Oral Tablet; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03545464

P160913

Details and patient eligibility

About

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

Full description

Acute urticaria (hives) is a common skin disease. The prevalence of acute urticaria in life is about 15 to 20% in the general population. It is responsible for a frequent use of emergency departments (ED). The usual treatment is based on early administration of an association of antihistamines and corticosteroid. The therapeutic efficacy of corticosteroids has never been established by high evidence studies. However, corticosteroids are frequently used. When stopped, corticosteroids could promote the occurence of urticaria recurrences, and a transition to chronic urticaria. In addition, corticosteroids may be rarely responsible for gastrointestinal bleeding, hypertension and diabetes.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Antihistamines + placebo of cortancyl

Experimental group

Description:

- In emergency department : Levocetirizine 5 mg orally. Renewable once if persistence of hives at 30 minutes. Placebo of Cortancyl : 1mg/kg (the number of tablets the patient needs to take is based on his weight and is noted on annex 4), once orally - At home : Levocetirizine 5 mg twice daily for 7 days (D1 to D7). If persistence of hives, levocetirizine 10 mg twice daily for 7 more days (D8 to D14). Placebo of Cortancyl 20 mg x 2 tablets = 40mg once per day for 3 days orally

Treatment:

Drug: Placebo Oral Tablet

Drug: Levocetirizine Oral Tablet

Association of antihistamines and cortancyl

Active Comparator group

Description:

- In emergency department : Levocetirizine 5 mg orally Renewable once if persistence of hives at 30 minutes. Cortancyl: 1 mg/kg (the number of tablets the patient needs to take is based on his weight and is noted on annex 4), once orally. - At home : Levocetirizine 5 mg twice daily for 7 days (D1 to D7). If persistence of hives, levocetirizine 10 mg twice daily for 7 more days (D8 to D14). Cortancyl : 20 mg x 2 tablets = 40 mg per day for 3 days orally

Treatment:

Drug: Cortancyl Oral Tablet

Drug: Levocetirizine Oral Tablet