COrticosteroids in acUte uRticAria in emerGency dEpartment

NCT ID: NCT03545464

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-21
• Study Completion Date: 2025-09-17

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.

Conditions

Urticaria; Angiœdema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Placebo Oral Tablet

Intervention Type: DRUG

Placebo of cortancyl Oral Tablet 20mg

Levocetirizine Oral Tablet

Intervention Type: DRUG

Levocetirizine Oral Tablet 5 mg

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

Group Type: ACTIVE_COMPARATOR

Cortancyl Oral Tablet

Intervention Type: DRUG

Cortancyl oral Tablet 20 mg

Levocetirizine Oral Tablet

Intervention Type: DRUG

Levocetirizine Oral Tablet 5 mg

Interventions

Placebo Oral Tablet

Placebo of cortancyl Oral Tablet 20mg

Intervention Type: DRUG

Cortancyl Oral Tablet

Cortancyl oral Tablet 20 mg

Intervention Type: DRUG

Levocetirizine Oral Tablet

Levocetirizine Oral Tablet 5 mg

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas JAVAUD, M.D,Ph.D

Role: PRINCIPAL_INVESTIGATOR

France Hospital Louis MOURIER Colombes, Ile De France, France, 92700

Locations

Hospital Louis MOURIER

Colombes, Île-de-France Region, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 31439599 (View on PubMed)

Other Identifiers

P160913J

Identifier Type: -

Identifier Source: org_study_id