COrticosteroids in acUte uRticAria in emerGency dEpartment

Urticaria Clinical Trial

— COURAGE  

Official title:

COrticosteroids in acUte uRticAria in emerGency dEpartment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03545464
• Other study ID #: P160913
• Status: Recruiting
• Phase: Phase 3
• Start date: September 21, 2019
• Est. completion date: September 21, 2025

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nicolas JAVAUD, M.D,Ph.D
• Phone: +33 1 47 60 64 42
• Email: nicolas.javaud[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 21, 2025
• Est. primary completion date: March 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angiœdema
• Angioedema
• Emergencies
• Urticaria

Intervention

Drug:
• Placebo Oral Tablet
Placebo of cortancyl Oral Tablet 20mg
• Cortancyl Oral Tablet
Cortancyl oral Tablet 20 mg
• Levocetirizine Oral Tablet
Levocetirizine Oral Tablet 5 mg

Locations

Country	Name	City	State
France	Hospital Louis MOURIER	Colombes	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Occurrence of spontaneous wheals and/or itch for > 6 weeks	wheals and/or itch for > 6 weeks	beyond 6 Weeks
Secondary	Patients with angioedema at day 7, 14 and 3 months	angioedema	up to 3 month
Secondary	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
Secondary	(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
Secondary	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