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Glucocorticoids With Antihistamines Versus Antihistamines in Acute Urticaria in Emergency (CAHISU)

T

Toulouse University Hospital

Status and phase

Completed
Phase 3
Phase 2

Conditions

Acute Urticaria

Treatments

Drug: prednisone
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02565680
11 221 02

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups, including a placebo group

placebo
Placebo Comparator group
Description:
tablets of Xyzall 5mg/ day during 5 days + placebo 40mg/ day during 4 days
Treatment:
Drug: placebo
prednisone
Experimental group
Description:
tablets of Xyzall 5 mg/j during 5 days + prednisone 40 mg/ day during 4 days
Treatment:
Drug: prednisone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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