Trial | NCT01940393  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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.
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 Started
Aug 31
2013
Primary Completion
Dec 31
2013
Study Completion
Jan 31
2014
Last Update
Feb 19
2014
Estimate

Drug Cetirizine

Drug administration

  • Other names: Alercet

Drug Desloratadine

Drug Administration

  • Other names: Aerius

Drug Fexofenadine

Drug administration

  • Other names: Allegra

Drug Ebastine

Drug administration

  • Other names: Pinaval

Drug Bilastine

Drug administration

  • Other names: Bilaxten

Ebastine Active Comparator

ebastine

Bilastine Active Comparator

bilastine

Cetirizine Active Comparator

Cetirizine

Desloratadine Active Comparator

desloratadine

Fexofenadine Active Comparator

Fexofenadine

Criteria 

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
No Results Posted