Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of participants with uticaria that improved Urticaria Activity Score and Life Quality Index (DLQI) with the use of antihistamine in mono-dose and quadruple dose.
研究概览
简要总结
The antihistamines with inhaled steroids are the cornerstone on the symptomatic therapy in the management of patients with rhinitis and the first line of treatment in patients with urticaria. Currently, the use of antihistamines has become popular due to its excellent safety profile and clinical efficacy, however to the investigators knowledge, there are no studies about the pharmacokinetic and pharmacodynamic effects of these drugs in patients of tropical Latin America. The investigators main interest is to evaluate if skin test inhibition correlates with the clinical effect of five anti-histamines.
详细描述
This was a randomized, double-blind, study that was conducted in six health care centers from Medellín and Bogotá (Colombia). This study was conducted in compliance with the ethical principles of the Declaration of Helsinki and with Good Clinical Practice guidelines. Written informed consent was obtained from all subjects or they parents in patients under 18 years. Ethical committee of University of Antioquia (Medellín, Colombia) approved the protocol. Considering the large number of articles that demonstrate the efficacy of antihistamines as first-line treatment in patients with urticaria, the ethics committee request that all participants would receive an antihistamine during the two months of the study because a placebo group would provide little information for the principal objective and the high risk of airway angioedema. Thirty heath subjects were used as a control group to evaluated the characteristics of the wheal in the prick test with histamine.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of persistent allergic urticaria.
- •Age over 12 years and at least one year with the disease
- •Informed consent filled.
- •Be resident of the metropolitan area of Medellin.
排除标准
- •• Use of immunosuppressive drugs
研究组 & 干预措施
Cetirizine
Cetirizine
干预措施: Cetirizine (Drug)
Desloratadine
desloratadine
干预措施: Desloratadine (Drug)
Fexofenadine
Fexofenadine
干预措施: Fexofenadine (Drug)
Ebastine
ebastine
干预措施: Ebastine (Drug)
Bilastine
bilastine
干预措施: Bilastine (Drug)
结局指标
主要结局
Number of participants with uticaria that improved Urticaria Activity Score and Life Quality Index (DLQI) with the use of antihistamine in mono-dose and quadruple dose.
时间窗: Patients will be followed for two months
Each patient will be assigned to receive the standard dose of one antihistamine for one month. The assignment of each patient group for each antihistamine will be using a double-blind system. In the second month, patients who do not achieve good control, will receive a quadrupled dose of the same antihistamine received in the first month. A medical evaluation, symptoms scales (UAS and DLQI) and prick test with histamine will be performed at enrollment and during the first and second months of follow up.
次要结局
- Safety issue(2 months)
- Cholinergic and physical urticarias(2 months)
研究者
Jorge Sanchez
M.D, M.Sc, Allergist
Grupo de Alergología Clínica y Experimental