Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria
Primary Purpose
Urticaria
Status
Completed
Phase
Phase 4
Locations
Colombia
Study Type
Interventional
Intervention
Cetirizine
Desloratadine
Fexofenadine
Ebastine
Bilastine
Sponsored by
About this trial
This is an interventional treatment trial for Urticaria focused on measuring urticaria, bilastine, fexofenadine, cetirizine, ebastine, desloratadine
Eligibility 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
Sites / Locations
- Medellin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Cetirizine
Desloratadine
Fexofenadine
Ebastine
Bilastine
Arm Description
Cetirizine
desloratadine
Fexofenadine
ebastine
bilastine
Outcomes
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.
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
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
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.
Full Information
NCT ID
NCT01940393
First Posted
August 26, 2013
Last Updated
February 16, 2014
Sponsor
Grupo de Alergología Clínica y Experimental
1. Study Identification
Unique Protocol Identification Number
NCT01940393
Brief Title
Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria
Official Title
Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grupo de Alergología Clínica y Experimental
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urticaria
Keywords
urticaria, bilastine, fexofenadine, cetirizine, ebastine, desloratadine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cetirizine
Arm Type
Active Comparator
Arm Description
Cetirizine
Arm Title
Desloratadine
Arm Type
Active Comparator
Arm Description
desloratadine
Arm Title
Fexofenadine
Arm Type
Active Comparator
Arm Description
Fexofenadine
Arm Title
Ebastine
Arm Type
Active Comparator
Arm Description
ebastine
Arm Title
Bilastine
Arm Type
Active Comparator
Arm Description
bilastine
Intervention Type
Drug
Intervention Name(s)
Cetirizine
Other Intervention Name(s)
Alercet
Intervention Description
Drug administration
Intervention Type
Drug
Intervention Name(s)
Desloratadine
Other Intervention Name(s)
Aerius
Intervention Description
Drug Administration
Intervention Type
Drug
Intervention Name(s)
Fexofenadine
Other Intervention Name(s)
Allegra
Intervention Description
Drug administration
Intervention Type
Drug
Intervention Name(s)
Ebastine
Other Intervention Name(s)
Pinaval
Intervention Description
Drug administration
Intervention Type
Drug
Intervention Name(s)
Bilastine
Other Intervention Name(s)
Bilaxten
Intervention Description
Drug administration
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Patients will be followed for two months
Secondary Outcome Measure Information:
Title
Safety issue
Description
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).
Time Frame
2 months
Title
Cholinergic and physical urticarias
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Sánchez, M.D
Organizational Affiliation
IPS Universitaria, University of Antioquia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medellin
City
Medellin
State/Province
Antioquia
Country
Colombia
12. IPD Sharing Statement
Citations:
PubMed Identifier
28709817
Citation
Sanchez J, Zakzuk J, Cardona R. Evaluation of a Guidelines-Based Approach to the Treatment of Chronic Spontaneous Urticaria. J Allergy Clin Immunol Pract. 2018 Jan-Feb;6(1):177-182.e1. doi: 10.1016/j.jaip.2017.06.002. Epub 2017 Jul 12.
Results Reference
derived
PubMed Identifier
27326985
Citation
Sanchez J, Zakzuk J, Cardona R. Prediction of the Efficacy of Antihistamines in Chronic Spontaneous Urticaria Based on Initial Suppression of the Histamine- Induced Wheal. J Investig Allergol Clin Immunol. 2016;26(3):177-84. doi: 10.18176/jiaci.0039.
Results Reference
derived
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Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria
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