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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01940393
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : February 19, 2014
Information provided by (Responsible Party):
Jorge Sanchez, Grupo de Alergología Clínica y Experimental

Brief 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.

Condition or disease Intervention/treatment Phase
Urticaria Drug: Cetirizine Drug: Desloratadine Drug: Fexofenadine Drug: Ebastine Drug: Bilastine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria
Study Start Date : August 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Histamine

Arm Intervention/treatment
Active Comparator: Cetirizine
Drug: Cetirizine
Drug administration
Other Name: Alercet

Active Comparator: Desloratadine
Drug: Desloratadine
Drug Administration
Other Name: Aerius

Active Comparator: Fexofenadine
Drug: Fexofenadine
Drug administration
Other Name: Allegra

Active Comparator: Ebastine
Drug: Ebastine
Drug administration
Other Name: Pinaval

Active Comparator: Bilastine
Drug: Bilastine
Drug administration
Other Name: Bilaxten

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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. 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.

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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01940393

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Medellin, Antioquia, Colombia
Sponsors and Collaborators
Grupo de Alergología Clínica y Experimental
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Principal Investigator: Jorge Sánchez, M.D IPS Universitaria, University of Antioquia
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jorge Sanchez, M.D, M.Sc, Allergist, Grupo de Alergología Clínica y Experimental Identifier: NCT01940393    
Other Study ID Numbers: GACE-01
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014
Keywords provided by Jorge Sanchez, Grupo de Alergología Clínica y Experimental:
Additional relevant MeSH terms:
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Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents