Glucocorticoids With Antihistamines Versus Antihistamines in Acute Urticaria in Emergency
- Registration Number
- NCT02565680
- Lead Sponsor
- University Hospital, Toulouse
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- adults
- urticaria rash no more 24 h duration and no take treatment for urticaria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo tablets of Xyzall 5mg/ day during 5 days + placebo 40mg/ day during 4 days prednisone prednisone tablets of Xyzall 5 mg/j during 5 days + prednisone 40 mg/ day during 4 days
- Primary Outcome Measures
Name Time Method To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours 48 hours To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours using the itch score
- Secondary Outcome Measures
Name Time Method Evolution of intensity pruritus, angioedema and rash with nine rule of Wallace 21 days 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
Recidive of urticaria 21 days The recidive of urticaria
The frequency of side-effects in either treatment group in 21 days 21 days The frequency of side-effects in either treatment group in 21 days
The observance treatment 21 days Observance treatment
The necessary time to decrease pruritus and rash 21 days The necessary time to decrease pruritus and rash
Trial Locations
- Locations (1)
CHU Toulouse
🇫🇷Toulouse, France