COrticosteroids in acUte uRticAria in emerGency dEpartment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- 7-Days Urticaria Activity Score (UAS 7) at day 7
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Antihistamines + placebo of cortancyl
- 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
干预措施: Placebo Oral Tablet (Drug)
Antihistamines + placebo of cortancyl
- 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
干预措施: Levocetirizine Oral Tablet (Drug)
Association of antihistamines and cortancyl
- 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
干预措施: Cortancyl Oral Tablet (Drug)
Association of antihistamines and cortancyl
- 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
干预措施: Levocetirizine Oral Tablet (Drug)
结局指标
主要结局
7-Days Urticaria Activity Score (UAS 7) at day 7
时间窗: 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.
次要结局
- 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)
- (DLQI) up to 6 months(up to 6 months)
- Recurrence of hives at day 7 and/or recurrence of itch at day 7(For 7 day)
- Occurrence of spontaneous wheals and/or itch for > 6 weeks(beyond 6 Weeks)
- Patients with angioedema at day 7, 14 and 3 months(up to 3 month)
- Cu-Q2QoL up to 6 months(at day 7, at day 14, at 6 week, at 3 months and 6 months)