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

Primary Purpose

Acute Urticaria

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
placebo
prednisone
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Urticaria focused on measuring acute urticaria, glucocorticoids, antihistamines, prurit, itch score, rash

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

prednisone

Arm Description

tablets of Xyzall 5mg/ day during 5 days + placebo 40mg/ day during 4 days

tablets of Xyzall 5 mg/j during 5 days + prednisone 40 mg/ day during 4 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
The necessary time to decrease pruritus and rash
The necessary time to decrease pruritus and rash
The frequency of side-effects in either treatment group in 21 days
The frequency of side-effects in either treatment group in 21 days
Recidive of urticaria
The recidive of urticaria
The observance treatment
Observance treatment

Full Information

First Posted
July 22, 2014
Last Updated
May 22, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02565680
Brief Title
Glucocorticoids With Antihistamines Versus Antihistamines in Acute Urticaria in Emergency
Acronym
CAHISU
Official Title
Glucocorticoids Associated With Antihistamines Versus Antihistamines Randomized Double Blinded for the Management of Acute Urticaria in Emergency
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Urticaria
Keywords
acute urticaria, glucocorticoids, antihistamines, prurit, itch score, rash

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
tablets of Xyzall 5mg/ day during 5 days + placebo 40mg/ day during 4 days
Arm Title
prednisone
Arm Type
Experimental
Arm Description
tablets of Xyzall 5 mg/j during 5 days + prednisone 40 mg/ day during 4 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Xyzall 5mg during 5 days + placebo 40mg during 4 days
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
Xyzall 5mg during 5 days + prednisone 40mg during 4 days
Primary Outcome Measure Information:
Title
To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours
Description
To compare treatment with prednisone and antihistamines versus antihistamines placebo to out acute urticaria in 48 hours using the itch score
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Evolution of intensity pruritus, angioedema and rash with nine rule of Wallace
Description
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
Time Frame
21 days
Title
The necessary time to decrease pruritus and rash
Description
The necessary time to decrease pruritus and rash
Time Frame
21 days
Title
The frequency of side-effects in either treatment group in 21 days
Description
The frequency of side-effects in either treatment group in 21 days
Time Frame
21 days
Title
Recidive of urticaria
Description
The recidive of urticaria
Time Frame
21 days
Title
The observance treatment
Description
Observance treatment
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Barniol, MD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28476259
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.
Results Reference
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Glucocorticoids With Antihistamines Versus Antihistamines in Acute Urticaria in Emergency

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