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

Sponsor

Grupo de Alergología Clínica y Experimental (Other)

Overall Status

Completed

CT.gov ID

NCT01940393

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

29.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Urticaria	Drug: Cetirizine Drug: Desloratadine Drug: Fexofenadine Drug: Ebastine Drug: Bilastine	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cetirizine Cetirizine	Drug: Cetirizine Drug administration Other Names: Alercet
Active Comparator: Desloratadine desloratadine	Drug: Desloratadine Drug Administration Other Names: Aerius
Active Comparator: Fexofenadine Fexofenadine	Drug: Fexofenadine Drug administration Other Names: Allegra
Active Comparator: Ebastine ebastine	Drug: Ebastine Drug administration Other Names: Pinaval
Active Comparator: Bilastine bilastine	Drug: Bilastine Drug administration Other Names: Bilaxten

Outcome Measures

Primary Outcome Measures

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. [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.

Secondary Outcome Measures

Safety issue [2 months]
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).
Cholinergic and physical urticarias [2 months]
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.