Back to resultsCOrticosteroids in acUte uRticAria in emerGency dEpartment (COURAGE)
Primary Purpose
Urticaria, Angiœdema
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Placebo Oral Tablet
Cortancyl Oral Tablet
Levocetirizine Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Urticaria focused on measuring Acute urticaria
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Isolated acute urticaria (acute hives): spontaneous urticaria, inducible urticaria
- Acute urticaria with angioedema without laryngeal edema
- Obtain patient's consent
- Social security affiliation
Exclusion Criteria:
- Pregnancy or breastfeeding
- Acute hives with anaphylaxis
- Bradykinin angioedema
- Angioedema without urticaria (hives)
- Laryngeal edema with urticaria (hives)
- Corticosteroid administration in the previous 5 days visiting the emergency department
- Antihistamines greater than 1 tablet per day in the previous 5 days visiting the ED
- Other treatment for urticaria : omalizumab, montelukast, ciclosporine A
- Chronic urticaria before acute urticaria diagnosis
- Atopic dermatitis
- Eczema
- Bullous pemphigoid
- Acute exanthematous pustulosis
- Diabetes mellitus
- Gastrointestinal ulcer
- Refusal to participate
- Known allergy to the study drugs or formulation ingredients
- Known Renal failure defined by creatinine clearance < 10 mL/min or cardiac failure defined by ejection fraction < 40%.
- Corticoid use in 5 days prior to randomisation
- Contra-indication to corticotherapy:
- Any live vaccine
- Psychotic states still uncontrolled by treatment limiting the participant's compliance with the research
Sites / Locations
- Hospital Louis MOURIERRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Antihistamines + placebo of cortancyl
Association of antihistamines and cortancyl
Arm Description
- In emergency department : Levocetirizine 5 mg orally. Renewable once if persistence of hives at 30 minutes. Placebo of Cortancyl : 1mg/kg (the number of tablets the patient needs to take is based on his weight and is noted on annex 4), once orally - At home : Levocetirizine 5 mg twice daily for 7 days (D1 to D7). If persistence of hives, levocetirizine 10 mg twice daily for 7 more days (D8 to D14). Placebo of Cortancyl 20 mg x 2 tablets = 40mg once per day for 3 days orally
- In emergency department : Levocetirizine 5 mg orally Renewable once if persistence of hives at 30 minutes. Cortancyl: 1 mg/kg (the number of tablets the patient needs to take is based on his weight and is noted on annex 4), once orally. - At home : Levocetirizine 5 mg twice daily for 7 days (D1 to D7). If persistence of hives, levocetirizine 10 mg twice daily for 7 more days (D8 to D14). Cortancyl : 20 mg x 2 tablets = 40 mg per day for 3 days orally
Outcomes
Primary Outcome Measures
7-Days Urticaria Activity Score (UAS 7) at day 7
Urticaria Activity Score (UAS) is a daily combined score of severity of itch and number of hives. Each component of the UAS is scored on a scale of 0 to 3; the 2 scores are added together for a daily total of 0 to 6.
Secondary Outcome Measures
Recurrence of hives at day 7 and/or recurrence of itch at day 7
The UAS 7 is the sum of the daily UAS scores over 7 days. This questionnaire will be completed by the patient and the investigator.
Occurrence of spontaneous wheals and/or itch for > 6 weeks
wheals and/or itch for > 6 weeks
Patients with angioedema at day 7, 14 and 3 months
angioedema
The reduction of morbidity is assessed by new emergency visits for acute urticaria recurrences at day 7, 14 and 3 months
emergency visits
(DLQI) up to 6 months
The DLQI is a dermatology-specific quality of life questionnaire designed for use in patients over 16 years of age
Cu-Q2QoL up to 6 months
The CU-Q2oL (French version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being
Full Information
NCT ID
NCT03545464
First Posted
April 13, 2018
Last Updated
December 7, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03545464
Brief Title
COrticosteroids in acUte uRticAria in emerGency dEpartment
Acronym
COURAGE
Official Title
COrticosteroids in acUte uRticAria in emerGency dEpartment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2019 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
September 21, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To demonstrate the non-inferiority of the efficacy of a single antihistamine in comparison with an association of antihistamine and corticosteroid in the treatment of acute urticaria in emergency departments
Detailed Description
Acute urticaria (hives) is a common skin disease. The prevalence of acute urticaria in life is about 15 to 20% in the general population. It is responsible for a frequent use of emergency departments (ED). The usual treatment is based on early administration of an association of antihistamines and corticosteroid. The therapeutic efficacy of corticosteroids has never been established by high evidence studies. However, corticosteroids are frequently used. When stopped, corticosteroids could promote the occurence of urticaria recurrences, and a transition to chronic urticaria. In addition, corticosteroids may be rarely responsible for gastrointestinal bleeding, hypertension and diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urticaria, Angiœdema
Keywords
Acute urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antihistamines + placebo of cortancyl
Arm Type
Experimental
Arm Description
- In emergency department : Levocetirizine 5 mg orally. Renewable once if persistence of hives at 30 minutes.
Placebo of Cortancyl : 1mg/kg (the number of tablets the patient needs to take is based on his weight and is noted on annex 4), once orally
- At home : Levocetirizine 5 mg twice daily for 7 days (D1 to D7). If persistence of hives, levocetirizine 10 mg twice daily for 7 more days (D8 to D14).
Placebo of Cortancyl 20 mg x 2 tablets = 40mg once per day for 3 days orally
Arm Title
Association of antihistamines and cortancyl
Arm Type
Active Comparator
Arm Description
- In emergency department : Levocetirizine 5 mg orally Renewable once if persistence of hives at 30 minutes.
Cortancyl: 1 mg/kg (the number of tablets the patient needs to take is based on his weight and is noted on annex 4), once orally.
- At home : Levocetirizine 5 mg twice daily for 7 days (D1 to D7). If persistence of hives, levocetirizine 10 mg twice daily for 7 more days (D8 to D14).
Cortancyl : 20 mg x 2 tablets = 40 mg per day for 3 days orally
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo of cortancyl Oral Tablet 20mg
Intervention Type
Drug
Intervention Name(s)
Cortancyl Oral Tablet
Intervention Description
Cortancyl oral Tablet 20 mg
Intervention Type
Drug
Intervention Name(s)
Levocetirizine Oral Tablet
Intervention Description
Levocetirizine Oral Tablet 5 mg
Primary Outcome Measure Information:
Title
7-Days Urticaria Activity Score (UAS 7) at day 7
Description
Urticaria Activity Score (UAS) is a daily combined score of severity of itch and number of hives. Each component of the UAS is scored on a scale of 0 to 3; the 2 scores are added together for a daily total of 0 to 6.
Time Frame
For 7 day
Secondary Outcome Measure Information:
Title
Recurrence of hives at day 7 and/or recurrence of itch at day 7
Description
The UAS 7 is the sum of the daily UAS scores over 7 days. This questionnaire will be completed by the patient and the investigator.
Time Frame
For 7 day
Title
Occurrence of spontaneous wheals and/or itch for > 6 weeks
Description
wheals and/or itch for > 6 weeks
Time Frame
beyond 6 Weeks
Title
Patients with angioedema at day 7, 14 and 3 months
Description
angioedema
Time Frame
up to 3 month
Title
The reduction of morbidity is assessed by new emergency visits for acute urticaria recurrences at day 7, 14 and 3 months
Description
emergency visits
Time Frame
up to 3 month
Title
(DLQI) up to 6 months
Description
The DLQI is a dermatology-specific quality of life questionnaire designed for use in patients over 16 years of age
Time Frame
up to 6 months
Title
Cu-Q2QoL up to 6 months
Description
The CU-Q2oL (French version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being
Time Frame
at day 7, at day 14, at 6 week, at 3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Isolated acute urticaria (acute hives): spontaneous urticaria, inducible urticaria
Acute urticaria with angioedema without laryngeal edema
Obtain patient's consent
Social security affiliation
Exclusion Criteria:
Pregnancy or breastfeeding
Acute hives with anaphylaxis
Bradykinin angioedema
Angioedema without urticaria (hives)
Laryngeal edema with urticaria (hives)
Corticosteroid administration in the previous 5 days visiting the emergency department
Antihistamines greater than 1 tablet per day in the previous 5 days visiting the ED
Other treatment for urticaria : omalizumab, montelukast, ciclosporin A
Chronic urticaria before acute urticaria diagnosis
Atopic dermatitis
Eczema
Bullous pemphigoid
Acute exanthematous pustulosis
Diabetes mellitus
Gastrointestinal ulcer
Refusal to participate
Known allergy to the study drugs or formulation ingredients
Known Renal failure defined by creatinine clearance < 10 mL/min or cardiac failure defined by ejection fraction < 40%.
Corticoid use in 5 days prior to randomisation
Contra-indication to corticotherapy:
Any live vaccine
Psychotic states still uncontrolled by treatment limiting the participant's compliance with the research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas JAVAUD, M.D,Ph.D
Phone
+33 1 47 60 64 42
Email
nicolas.javaud@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fréderic ADNET, M.D,Ph.D
Phone
+33 1 48 96 44 08
Email
frederic.adnet@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas JAVAUD, M.D,Ph.D
Organizational Affiliation
France Hospital Louis MOURIER Colombes, Ile De France, France, 92700
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Louis MOURIER
City
Colombes
State/Province
Ile De France
ZIP/Postal Code
92700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas JAVAUD, M.D, Ph.D
Phone
+33 1 47 60 64 42
Email
nicolas.javaud@aphp.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
31439599
Citation
Javaud N, Soria A, Maignan M, Martin L, Descamps V, Fain O, Bouillet L, Berard F, Tazarourte K, Roy PM, Fontaine JP, Bagot M, Khellaf M, Goulet H, Lapostolle F, Casalino E, Doutre MS, Gil-Jardine C, Caux F, Chosidow O, Pateron D, Vicaut E, Adnet F. Glucocorticoids for acute urticaria: study protocol for a double-blind non-inferiority randomised controlled trial. BMJ Open. 2019 Aug 21;9(8):e027431. doi: 10.1136/bmjopen-2018-027431.
Results Reference
derived
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COrticosteroids in acUte uRticAria in emerGency dEpartment
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