Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria
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|ClinicalTrials.gov Identifier: NCT01940393|
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : February 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Urticaria||Drug: Cetirizine Drug: Desloratadine Drug: Fexofenadine Drug: Ebastine Drug: Bilastine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||January 2014|
Active Comparator: Cetirizine
Other Name: Alercet
Active Comparator: Desloratadine
Other Name: Aerius
Active Comparator: Fexofenadine
Other Name: Allegra
Active Comparator: Ebastine
Other Name: Pinaval
Active Comparator: Bilastine
Other Name: Bilaxten
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940393
|Medellin, Antioquia, Colombia|
|Principal Investigator:||Jorge Sánchez, M.D||IPS Universitaria, University of Antioquia|