Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria

Urticaria Clinical Trial

Official title:

Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940393
• Other study ID #: GACE-01
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2013
• Last updated: February 16, 2014
• Start date: August 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Grupo de Alergología Clínica y Experimental
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: National Institutes of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• • Use of immunosuppressive drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urticaria

Intervention

Drug:
• Cetirizine
Drug administration
• Desloratadine
Drug Administration
• Fexofenadine
Drug administration
• Ebastine
Drug administration
• Bilastine
Drug administration

Locations

Country	Name	City	State
Colombia	Medellin	Medellin	Antioquia

Sponsors (1)

Lead Sponsor	Collaborator
Grupo de Alergología Clínica y Experimental

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Patients will be followed for two months	No
Secondary	Safety issue	Safety and tolerability were assessed by adverse events reported by subjects at each postrandomization clinic visit. We did electrocardiogram and laboratory examination before initiation of antihistamine therapy and each month after (complete blood count [CBC], aspartate aminotransferase [AST], alanine aminotransferase [ALT], creatinine, blood urea nitrogen). We did an specific questionnaire (in spanish) to assess sedation: "¿Sientes más sueño o somnolencia de lo acostumbrado?" (Do you feel more sleepy or drowsy than usual?), "¿Sientes que el sueño o la somnolencia interfiere con tus actividades diarias?" (Do you feel sleep or sleepiness interferes with your daily activities?), "¿Sientes que tú sueño no es reparador?" (Do you feel that you sleep is not restful?). Each question could be answered from 0 to 3 points (0 no 1. little, 2 moderate, 3 much). the sum of points defined them the severity of sedation in mild (0-3), moderate (4-5) and severe sedation (6-9).	2 months	Yes
Secondary	Cholinergic and physical urticarias	We asked to each patients about physical triggers and with physical provocation test, we evaluated in all patients if wheals are evoked by a cholinergic or physical stimulus such as water, pressure, friction or cold contact.	2 months	No