Glucocorticoids With Antihistamines Versus Antihistamines in Acute Urticaria in Emergency

Study Overview
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Brief Summary
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Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before.

Detailed Description
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Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. Acute urticaria is pruritic and incapacitating for daily life. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before. One group randomized received 40mg of cortancyl and 1 pill of citerizine and another group randomized received 1 pill citerizine and placebo like cortancyl. Pharmacy hospital takes care of randomization. Pruritus evaluated with icth score and rash evaluated with nine rule of Wallace, the patient is evaluated in T0, one hour after and contacted by telephone at J2, J5, J15, J 21 itch score, Wallace extension, observance, side effects are asked him.

Official Title
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Glucocorticoids Associated With Antihistamines Versus Antihistamines Randomized Double Blinded for the Management of Acute Urticaria in Emergency

Conditions
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Acute Urticaria

Intervention / Treatment
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* Drug: placebo
* Drug: prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults urticaria rash no more 24 h duration and no take treatment for urticaria Exclusion Criteria: patients were presented severe anaphylaxis or taken antihistamines or glucocorticoids within 5 days of arrival at ED, severe infection pregnancy patients BPCO diabetics allergy corticosteroids refusal to comply participate an other study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>tablets of Xyzall 5mg/ day during 5 days + placebo 40mg/ day during 4 days | Drug: placebo<br>* Xyzall 5mg during 5 days + placebo 40mg during 4 days<br>|
| Experimental: prednisone<br>tablets of Xyzall 5 mg/j during 5 days + prednisone 40 mg/ day during 4 days | Drug: prednisone<br>* Xyzall 5mg during 5 days + prednisone 40mg during 4 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours | To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours using the itch score | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of intensity pruritus, angioedema and rash with nine rule of Wallace | Evolution of intensity pruritus at T0 and T1, J2, J5, J15, J21 and angioedema and rash at T1, J2, J5, J15 and J21 comparing at T0 with nine rule of Wallace | 21 days | 
| The necessary time to decrease pruritus and rash | The necessary time to decrease pruritus and rash | 21 days | 
| The frequency of side-effects in either treatment group in 21 days | The frequency of side-effects in either treatment group in 21 days | 21 days | 
| Recidive of urticaria | The recidive of urticaria | 21 days | 
| The observance treatment | Observance treatment | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute urticaria, glucocorticoids, antihistamines, prurit, itch score, rash