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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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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

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Urticaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cetirizine

Group Type ACTIVE_COMPARATOR

Cetirizine

Intervention Type DRUG

Drug administration

Desloratadine

desloratadine

Group Type ACTIVE_COMPARATOR

Desloratadine

Intervention Type DRUG

Drug Administration

Fexofenadine

Group Type ACTIVE_COMPARATOR

Fexofenadine

Intervention Type DRUG

Drug administration

Ebastine

ebastine

Group Type ACTIVE_COMPARATOR

Ebastine

Intervention Type DRUG

Drug administration

Bilastine

bilastine

Group Type ACTIVE_COMPARATOR

Bilastine

Intervention Type DRUG

Drug administration

Interventions

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Cetirizine

Drug administration

Intervention Type DRUG

Desloratadine

Drug Administration

Intervention Type DRUG

Fexofenadine

Drug administration

Intervention Type DRUG

Ebastine

Drug administration

Intervention Type DRUG

Bilastine

Drug administration

Intervention Type DRUG

Other Intervention Names

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Alercet Aerius Allegra Pinaval Bilaxten

Eligibility Criteria

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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.