COrticosteroids in acUte uRticAria in emerGency dEpartment (COURAGE)

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

Study Overview

• Status: Recruiting
• Conditions: Urticaria; Angiœdema
• Intervention / Treatment: Drug: Placebo Oral Tablet; Drug: Levocetirizine Oral Tablet; Drug: Cortancyl Oral Tablet

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 Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nicolas JAVAUD, M.D,Ph.D; Phone Number: +33 1 47 60 64 42; Email: nicolas.javaud@aphp.fr
• Study Contact Backup: Name: Fréderic ADNET, M.D,Ph.D; Phone Number: +33 1 48 96 44 08; Email: frederic.adnet@aphp.fr

Study Locations

• France
  • Ile De France
    • Colombes, Ile De France, France, 92700
      • Recruiting
      • Hospital Louis MOURIER
      • Contact: Nicolas JAVAUD, M.D, Ph.D; Phone Number: +33 1 47 60 64 42; Email: nicolas.javaud@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: Levocetirizine Oral Tablet; Levocetirizine Oral Tablet 5 mg; Drug: Cortancyl Oral Tablet; Cortancyl oral Tablet 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	For 7 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	For 7 day
Occurrence of spontaneous wheals and/or itch for > 6 weeks	wheals and/or itch for > 6 weeks	beyond 6 Weeks
Patients with angioedema at day 7, 14 and 3 months	angioedema	up to 3 month
The reduction of morbidity is assessed by new emergency visits for acute urticaria recurrences at day 7, 14 and 3 months	emergency visits	up to 3 month
(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	up to 6 months
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	at day 7, at day 14, at 6 week, at 3 months and 6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Nicolas JAVAUD, M.D,Ph.D, France Hospital Louis MOURIER Colombes, Ile De France, France, 92700

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2019
• Primary Completion (Estimated): March 28, 2025
• Study Completion (Estimated): September 21, 2025

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Acute urticaria
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Disease Attributes; Skin Diseases, Vascular; Hypersensitivity; Emergencies; Angioedema; Urticaria; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Prednisone; Levocetirizine
• Other Study ID Numbers: P160913

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No