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

February 16, 2014 updated by: Jorge Sanchez, Grupo de Alergología Clínica y Experimental
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Medellin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cetirizine
Drug: Cetirizine
Drug administration
Other Names:
  • Alercet
Active Comparator: Desloratadine
desloratadine
Drug: Desloratadine
Drug Administration
Other Names:
  • Aerius
Active Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
Patients will be followed for two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety issue
Time Frame: 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).
2 months
Cholinergic and physical urticarias
Time Frame: 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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Alergología Clínica y Experimental

Investigators

  • Principal Investigator: Jorge Sánchez, M.D, IPS Universitaria, University of Antioquia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

September 8, 2013

First Posted (Estimate)

September 12, 2013

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 16, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GACE-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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