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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jorge Sanchez, Grupo de Alergología Clínica y Experimental
ClinicalTrials.gov Identifier:
NCT01940393
First received: August 26, 2013
Last updated: February 16, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Urticaria
Drug: Cetirizine
Drug: Desloratadine
Drug: Fexofenadine
Drug: Ebastine
Drug: Bilastine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria

Resource links provided by NLM:


Further study details as provided by Grupo de Alergología Clínica y Experimental:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • Safety issue [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

    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).


  • Cholinergic and physical urticarias [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 150
Study Start Date: August 2013
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cetirizine
Cetirizine
Drug: Cetirizine
Drug administration
Other Name: Alercet
Active Comparator: Desloratadine
desloratadine
Drug: Desloratadine
Drug Administration
Other Name: Aerius
Active Comparator: Fexofenadine
Fexofenadine
Drug: Fexofenadine
Drug administration
Other Name: Allegra
Active Comparator: Ebastine
ebastine
Drug: Ebastine
Drug administration
Other Name: Pinaval
Active Comparator: Bilastine
bilastine
Drug: Bilastine
Drug administration
Other Name: Bilaxten

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.

  Eligibility

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01940393

Locations
Colombia
Medellin
Medellin, Antioquia, Colombia
Sponsors and Collaborators
Grupo de Alergología Clínica y Experimental
Investigators
Principal Investigator: Jorge Sánchez, M.D IPS Universitaria, University of Antioquia
  More Information

No publications provided

Responsible Party: Jorge Sanchez, M.D, M.Sc, Allergist, Grupo de Alergología Clínica y Experimental
ClinicalTrials.gov Identifier: NCT01940393     History of Changes
Other Study ID Numbers: GACE-01
Study First Received: August 26, 2013
Last Updated: February 16, 2014
Health Authority: Colombia: National Institutes of Health

Keywords provided by Grupo de Alergología Clínica y Experimental:
urticaria
bilastine
fexofenadine
cetirizine
ebastine
desloratadine

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine Antagonists
Cetirizine
Ebastine
Desloratadine
Fexofenadine
Terfenadine
Histamine H1 Antagonists
Histamine
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine Agonists
Anti-Allergic Agents
Therapeutic Uses
Histamine H1 Antagonists, Non-Sedating
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on August 28, 2014