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Completed

NCT Number: NCT02565680

Glucocorticoids With Antihistamines Versus Antihistamines in Acute Urticaria in Emergency

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CHU Toulouse

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Xyzall 5mg during 5 days + placebo 40mg during 4 days

Prednisone

Drug

Xyzall 5mg during 5 days + prednisone 40mg during 4 days

Primary outcomes

  1. To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours

    Time frame: 48 hours

    To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours using the itch score

Secondary outcomes

  1. Evolution of intensity pruritus, angioedema and rash with nine rule of Wallace

    Time frame: 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

  2. The necessary time to decrease pruritus and rash

    Time frame: 21 days

    The necessary time to decrease pruritus and rash

  3. The frequency of side-effects in either treatment group in 21 days

    Time frame: 21 days

    The frequency of side-effects in either treatment group in 21 days

  4. Recidive of urticaria

    Time frame: 21 days

    The recidive of urticaria

  5. The observance treatment

    Time frame: 21 days

    Observance treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: CAHISU

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 1, 2015
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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