COrticosteroids in acUte uRticAria in emerGency dEpartment
- Conditions
- UrticariaAngiœdema
- Interventions
- Registration Number
- NCT03545464
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Association of antihistamines and cortancyl Cortancyl Oral Tablet - 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 Association of antihistamines and cortancyl Levocetirizine Oral Tablet - 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 Antihistamines + placebo of cortancyl Placebo Oral Tablet - 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 Antihistamines + placebo of cortancyl Levocetirizine Oral Tablet - 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
- Primary Outcome Measures
Name Time Method 7-Days Urticaria Activity Score (UAS 7) at day 7 For 7 day 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.
- Secondary Outcome Measures
Name Time Method The reduction of morbidity is assessed by new emergency visits for acute urticaria recurrences at day 7, 14 and 3 months up to 3 month emergency visits
(DLQI) up to 6 months up to 6 months The DLQI is a dermatology-specific quality of life questionnaire designed for use in patients over 16 years of age
Recurrence of hives at day 7 and/or recurrence of itch at day 7 For 7 day 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.
Occurrence of spontaneous wheals and/or itch for > 6 weeks beyond 6 Weeks wheals and/or itch for \> 6 weeks
Patients with angioedema at day 7, 14 and 3 months up to 3 month angioedema
Cu-Q2QoL up to 6 months at day 7, at day 14, at 6 week, at 3 months and 6 months The CU-Q2oL (French version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being
Trial Locations
- Locations (1)
Hospital Louis MOURIER
🇫🇷Colombes, Ile De France, France