UrticariaPhase 4NCT01940393
Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria
A Phase 4 study testing Cetirizine, Desloratadine and Fexofenadine in people with Urticaria, run by Grupo de Alergología Clínica y Experimental at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Urticaria
- What is being tested?
- Cetirizine, Desloratadine and Fexofenadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteColombia
- Study dates
- Aug 2013to Jan 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- • Use of immunosuppressive drugs
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Urticaria
- Being tested
- Cetirizine, Desloratadine, Fexofenadine, Ebastine, Bilastine
- Keywords
- urticaria, bilastine, fexofenadine, cetirizine, ebastine, desloratadine
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetirizineDrug
Also called Alercet
Drug administration
DesloratadineDrug
Also called Aerius
Drug Administration
FexofenadineDrug
Also called Allegra
Drug administration
EbastineDrug
Also called Pinaval
Drug administration
BilastineDrug
Also called Bilaxten
Drug administration
| Study group | Role | What they receive |
|---|---|---|
| Cetirizine | Active comparator | Cetirizine Receives: Drug: Cetirizine |
| Desloratadine | Active comparator | desloratadine Receives: Drug: Desloratadine |
| Fexofenadine | Active comparator | Fexofenadine Receives: Drug: Fexofenadine |
| Ebastine | Active comparator | ebastine Receives: Drug: Ebastine |
| Bilastine | Active comparator | bilastine Receives: Drug: Bilastine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patients will be followed for two months
Secondary outcomes (2)
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).
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Alergología Clínica y Experimental
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Sanchez, Grupo de Alergología Clínica y Experimental
- Investigators
- Jorge Sánchez, M.D, Principal investigator, IPS Universitaria, University of Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940393
- Sponsor's protocol ID
- GACE-01
- Status last verified
- Feb 2014
- First submitted
- 26 Aug 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28709817Sanchez 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.
PubMed 27326985
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria
- ClinicalTrials.gov ID
- NCT01940393
- Acronym / sponsor ID
- GACE-01
- Conditions
- Urticaria
- Keywords
- urticaria, bilastine, fexofenadine, cetirizine, ebastine, desloratadine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Grupo de Alergología Clínica y ExperimentalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cetirizine | Active comparator | Drug: CetirizineCetirizine |
| Desloratadine | Active comparator | Drug: Desloratadinedesloratadine |
| Fexofenadine | Active comparator | Drug: FexofenadineFexofenadine |
| Ebastine | Active comparator | Drug: Ebastineebastine |
| Bilastine | Active comparator | Drug: Bilastinebilastine |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- • Use of immunosuppressive drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetirizineAlso: AlercetDrug administration | Drug | Cetirizine |
| DesloratadineAlso: AeriusDrug Administration | Drug | Desloratadine |
| FexofenadineAlso: AllegraDrug administration | Drug | Fexofenadine |
| EbastineAlso: PinavalDrug administration | Drug | Ebastine |
| BilastineAlso: BilaxtenDrug administration | Drug | Bilastine |
Primary outcome
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.
2 secondary outcomes
Safety issue
Time frame: 2 months
Cholinergic and physical urticarias
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
- Derived from this study: PubMed 28709817Sanchez 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.
- Derived from this study: PubMed 27326985Sanchez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Sánchez, M.D principal investigator
IPS Universitaria, University of Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cetirizine, Desloratadine and Fexofenadine in people with Urticaria, run by Grupo de Alergología Clínica y Experimental at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01940393, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.