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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.
 
ClinicalTrials.gov Identifier: NCT01940393
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
Jorge Sanchez, Grupo de Alergología Clínica y Experimental

Tracking Information
First Submitted Date  ICMJE August 26, 2013
First Posted Date  ICMJE September 12, 2013
Last Update Posted Date February 19, 2014
Study Start Date  ICMJE August 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2013)
Number of participants with uticaria that improved total symptom scores (TSS3) 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 (TSS3 and DLQI) and prick test with histamine will be performed at enrollment and during the first and second months of follow up.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2014)
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria
Official Title  ICMJE Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Urticaria
Intervention  ICMJE
  • Drug: Cetirizine
    Drug administration
    Other Name: Alercet
  • Drug: Desloratadine
    Drug Administration
    Other Name: Aerius
  • Drug: Fexofenadine
    Drug administration
    Other Name: Allegra
  • Drug: Ebastine
    Drug administration
    Other Name: Pinaval
  • Drug: Bilastine
    Drug administration
    Other Name: Bilaxten
Study Arms  ICMJE
  • Active Comparator: Cetirizine
    Cetirizine
    Intervention: Drug: Cetirizine
  • Active Comparator: Desloratadine
    desloratadine
    Intervention: Drug: Desloratadine
  • Active Comparator: Fexofenadine
    Fexofenadine
    Intervention: Drug: Fexofenadine
  • Active Comparator: Ebastine
    ebastine
    Intervention: Drug: Ebastine
  • Active Comparator: Bilastine
    bilastine
    Intervention: Drug: Bilastine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2013)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01940393
Other Study ID Numbers  ICMJE GACE-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jorge Sanchez, Grupo de Alergología Clínica y Experimental
Study Sponsor  ICMJE Grupo de Alergología Clínica y Experimental
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jorge Sánchez, M.D IPS Universitaria, University of Antioquia
PRS Account Grupo de Alergología Clínica y Experimental
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP