NCT01940393

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Grupo de Alergología Clínica y Experimental · Academic / Other
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Urticaria

Interventions

Type	Name	Description
DRUG	Cetirizine	Drug administration
DRUG	Desloratadine	Drug Administration
DRUG	Fexofenadine	Drug administration
DRUG	Ebastine	Drug administration
DRUG	Bilastine	Drug administration

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2013-09-12
• Last updated: 2014-02-19

Locations

1 site across 1 country: Colombia