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

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

Tracking Information

• First Submitted Date: August 26, 2013
• First Posted Date: September 12, 2013
• Last Update Posted Date: February 19, 2014
• Study Start Date: August 2013
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Urticaria

Intervention

• 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

• 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 *

• Sánchez 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.
• Sánchez 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 8, 2013): 150
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 50 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Colombia

Administrative Information

• NCT Number: NCT01940393
• Other Study ID Numbers: GACE-01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jorge Sanchez, Grupo de Alergología Clínica y Experimental
• Study Sponsor: Grupo de Alergología Clínica y Experimental
• Collaborators: Not Provided

Investigators

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

• PRS Account: Grupo de Alergología Clínica y Experimental
• Verification Date: February 2014