COrticosteroids in acUte uRticAria in emerGency dEpartment

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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COrticosteroids in acUte uRticAria in emerGency dEpartment

Conditions
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Urticaria, Angiœdema

Intervention / Treatment
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* Drug: Placebo Oral Tablet
* Drug: Cortancyl Oral Tablet
* Drug: Levocetirizine Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antihistamines + placebo of cortancyl<br>- 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 | Drug: Placebo Oral Tablet<br>* Placebo of cortancyl Oral Tablet 20mg<br>Drug: Levocetirizine Oral Tablet<br>* Levocetirizine Oral Tablet 5 mg<br>|
| Active Comparator: Association of antihistamines and cortancyl<br>- 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 | Drug: Cortancyl Oral Tablet<br>* Cortancyl oral Tablet 20 mg<br>Drug: Levocetirizine Oral Tablet<br>* Levocetirizine Oral Tablet 5 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-Days Urticaria Activity Score (UAS 7) at day 7 | Urticaria Activity Score (UAS) is a daily combined score of severity of itch and number of hives. Each component of the UAS is scored on a scale of 0 to 3; the 2 scores are added together for a daily total of 0 to 6. | For 7 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of hives at day 7 and/or recurrence of itch at day 7 | The UAS 7 is the sum of the daily UAS scores over 7 days. This questionnaire will be completed by the patient and the investigator. | For 7 day | 
| Occurrence of spontaneous wheals and/or itch for > 6 weeks | wheals and/or itch for > 6 weeks | beyond 6 Weeks | 
| Patients with angioedema at day 7, 14 and 3 months | angioedema | up to 3 month | 
| The reduction of morbidity is assessed by new emergency visits for acute urticaria recurrences at day 7, 14 and 3 months | emergency visits | up to 3 month | 
| (DLQI) up to 6 months | The DLQI is a dermatology-specific quality of life questionnaire designed for use in patients over 16 years of age | up to 6 months | 
| Cu-Q2QoL up to 6 months | The CU-Q2oL (French version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being | at day 7, at day 14, at 6 week, at 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute urticaria