NCT01940393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

4 months

First QC Date

August 26, 2013

Last Update Submit

February 16, 2014

Conditions

Urticaria

Keywords

urticariabilastinefexofenadinecetirizineebastinedesloratadine

Outcome Measures

Primary Outcomes (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.

    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.

    Patients will be followed for two months

Secondary Outcomes (2)

  • Safety issue

    2 months

  • Cholinergic and physical urticarias

    2 months

Study Arms (5)

Cetirizine

ACTIVE COMPARATOR

Cetirizine

Drug: Cetirizine

Desloratadine

ACTIVE COMPARATOR

desloratadine

Drug: Desloratadine

Fexofenadine

ACTIVE COMPARATOR

Fexofenadine

Drug: Fexofenadine

Ebastine

ACTIVE COMPARATOR

ebastine

Drug: Ebastine

Bilastine

ACTIVE COMPARATOR

bilastine

Drug: Bilastine

Interventions

CetirizineDRUG

Drug administration

Also known as: Alercet
Cetirizine
DesloratadineDRUG

Drug Administration

Also known as: Aerius
Desloratadine
FexofenadineDRUG

Drug administration

Also known as: Allegra
Fexofenadine
EbastineDRUG

Drug administration

Also known as: Pinaval
Ebastine
BilastineDRUG

Drug administration

Also known as: Bilaxten
Bilastine

Eligibility Criteria

Age12 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Use of immunosuppressive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medellin

Medellín, Antioquia, Colombia

Location

Related Publications (2)

  • 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.

    PMID: 28709817DERIVED

  • 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.

    PMID: 27326985DERIVED

MeSH Terms

Conditions

Urticaria

Interventions

Cetirizinedesloratadinefexofenadineebastinebilastine

Condition Hierarchy (Ancestors)

Skin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jorge Sánchez, M.D

    IPS Universitaria, University of Antioquia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, M.Sc, Allergist

Study Record Dates

First Submitted

August 26, 2013

First Posted

September 12, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

CO(1)