Clinical trial NCT02565680: Glucocorticoids With Antihistamines Versus Antihistamines in Acute Urticaria in Emergency
Official title: Glucocorticoids Associated With Antihistamines Versus Antihistamines Randomized Double Blinded for the Management of Acute Urticaria in Emergency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Urticaria
Keywords: acute urticaria
glucocorticoids
antihistamines
prurit
itch score
rash
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours
timeFrame: 48 hours
Secondary outcomes:
measure: Evolution of intensity pruritus, angioedema and rash with nine rule of Wallace
timeFrame: 21 days
measure: The necessary time to decrease pruritus and rash
timeFrame: 21 days
measure: The frequency of side-effects in either treatment group in 21 days
timeFrame: 21 days
measure: Recidive of urticaria
timeFrame: 21 days
measure: The observance treatment
timeFrame: 21 days
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Caroline Barniol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barniol C, Dehours E, Mallet J, Houze-Cerfon CH, Lauque D, Charpentier S. Levocetirizine and Prednisone Are Not Superior to Levocetirizine Alone for the Treatment of Acute Urticaria: A Randomized Double-Blind Clinical Trial. Ann Emerg Med. 2018 Jan;71(1):125-131.e1. doi: 10.1016/j.annemergmed.2017.03.006. Epub 2017 May 3.