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

Grupo de Alergología Clínica y Experimental

Status and phase: Completed; Phase 4

Conditions: Urticaria

Treatments: Drug: Desloratadine; Drug: Cetirizine; Drug: Fexofenadine; Drug: Ebastine; Drug: Bilastine

Study type: Interventional

Funder types: Other

Identifiers

NCT01940393

GACE-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 12 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 5 patient groups

Cetirizine

Active Comparator group

Description:

Cetirizine

Treatment:

Drug: Cetirizine

Desloratadine

Active Comparator group

Description:

desloratadine

Treatment:

Drug: Desloratadine

Fexofenadine

Active Comparator group

Description:

Fexofenadine

Treatment:

Drug: Fexofenadine

Ebastine

Active Comparator group

Description:

ebastine

Treatment:

Drug: Ebastine

Bilastine

Active Comparator group

Description:

bilastine

Treatment:

Drug: Bilastine