Glucocorticoids With Antihistamines Versus Antihistamines in Acute Urticaria in Emergency

Acute Urticaria Clinical Trial

— CAHISU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565680
• Other study ID #: 11 221 02
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2012
• Est. completion date: February 2014

Study information

• Verified date: May 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Urticaria
• Emergencies
• Urticaria

Intervention

Drug:
• placebo
Xyzall 5mg during 5 days + placebo 40mg during 4 days
• prednisone
Xyzall 5mg during 5 days + prednisone 40mg during 4 days

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The necessary time to decrease pruritus and rash	The necessary time to decrease pruritus and rash	21 days
Secondary	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
Secondary	Recidive of urticaria	The recidive of urticaria	21 days
Secondary	The observance treatment	Observance treatment	21 days