Glucocorticoids Associated With Antihistamines Versus Antihistamines Randomized Double Blinded for the Management of Acute Urticaria in Emergency
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours
研究概览
简要总结
Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before.
详细描述
Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. Acute urticaria is pruritic and incapacitating for daily life. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before. One group randomized received 40mg of cortancyl and 1 pill of citerizine and another group randomized received 1 pill citerizine and placebo like cortancyl. Pharmacy hospital takes care of randomization. Pruritus evaluated with icth score and rash evaluated with nine rule of Wallace, the patient is evaluated in T0, one hour after and contacted by telephone at J2, J5, J15, J 21 itch score, Wallace extension, observance, side effects are asked him.
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
- •urticaria rash no more 24 h duration and no take treatment for urticaria
排除标准
- •patients were presented severe anaphylaxis or taken antihistamines or glucocorticoids within 5 days of arrival at ED,
- •severe infection
- •pregnancy
- •patients BPCO
- •diabetics
- •allergy corticosteroids
- •refusal to comply
- •participate an other study
研究组 & 干预措施
placebo
tablets of Xyzall 5mg/ day during 5 days + placebo 40mg/ day during 4 days
干预措施: placebo (Drug)
prednisone
tablets of Xyzall 5 mg/j during 5 days + prednisone 40 mg/ day during 4 days
干预措施: prednisone (Drug)
结局指标
主要结局
To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours
时间窗: 48 hours
To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours using the itch score
次要结局
- Evolution of intensity pruritus, angioedema and rash with nine rule of Wallace(21 days)
- Recidive of urticaria(21 days)
- The frequency of side-effects in either treatment group in 21 days(21 days)
- The observance treatment(21 days)
- The necessary time to decrease pruritus and rash(21 days)