COURAGE: COrticosteroids in acUte uRticAria in emerGency dEpartment

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT03545464

Collaborator

(none)

240

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To demonstrate the non-inferiority of the efficacy of a single antihistamine in comparaison with an association of antihistamine and corticosteroid in the treatment of acute urticaria in emergency departments

Condition or Disease	Intervention/Treatment	Phase
Urticaria Angiœdema	Drug: Placebo Oral Tablet Drug: Cortancyl Oral Tablet Drug: Levocetirizine Oral Tablet	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

COrticosteroids in acUte uRticAria in emerGency dEpartment

Actual Study Start Date :

Sep 21, 2019

Actual Primary Completion Date :

Sep 28, 2021

Anticipated Study Completion Date :

Mar 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Antihistamines + placebo of cortancyl - 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	Drug: Placebo Oral Tablet Placebo of cortancyl Oral Tablet 20mg Drug: Levocetirizine Oral Tablet Levocetirizine Oral Tablet 5 mg
Active Comparator: Association of antihistamines and cortancyl - 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	Drug: Cortancyl Oral Tablet Cortancyl oral Tablet 20 mg Drug: Levocetirizine Oral Tablet Levocetirizine Oral Tablet 5 mg

Arm

Intervention/Treatment

Experimental: Antihistamines + placebo of cortancyl

- 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

Drug: Placebo Oral Tablet

Placebo of cortancyl Oral Tablet 20mg

Drug: Levocetirizine Oral Tablet

Levocetirizine Oral Tablet 5 mg

Active Comparator: Association of antihistamines and cortancyl

- 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

Drug: Cortancyl Oral Tablet

Cortancyl oral Tablet 20 mg

Drug: Levocetirizine Oral Tablet

Levocetirizine Oral Tablet 5 mg

Outcome Measures

Primary Outcome Measures

7-Days Urticaria Activity Score (UAS 7) at day 7 [For 7 day]
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 [For 7 day]
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 [beyond 6 Weeks]
wheals and/or itch for > 6 weeks
Patients with angioedema at day 7, 14 and 3 months [up to 3 month]
angioedema
The reduction of morbidity is assessed by new emergency visits for acute urticaria recurrences at day 7, 14 and 3 months [up to 3 month]
emergency visits
(DLQI) up to 6 months [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 [at day 7, at day 14, at 6 week, at 3 months and 6 months]
The CU-Q2oL (French version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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