COrticosteroids in acUte uRticAria in emerGency dEpartment

NCT03545464 | Completed Phase 3

• 1 other identifier: P160913J
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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

Conditions

Urticaria; Angiœdema

Keywords

Acute urticaria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Recurrence of hives at day 7 and/or recurrence of itch at day 7

  For 7 day

• Occurrence of spontaneous wheals and/or itch for > 6 weeks

  beyond 6 Weeks

• Patients with angioedema at day 7, 14 and 3 months

  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

  up to 3 month

• (DLQI) up to 6 months

  up to 6 months

Study Arms (2)

Antihistamines + placebo of cortancyl

EXPERIMENTAL

\- 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; Drug: Levocetirizine Oral Tablet

Association of antihistamines and cortancyl

ACTIVE COMPARATOR

\- 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; Drug: Levocetirizine Oral Tablet

Interventions

Placebo Oral Tablet DRUG

Placebo of cortancyl Oral Tablet 20mg

Antihistamines + placebo of cortancyl

Cortancyl Oral Tablet DRUG

Cortancyl oral Tablet 20 mg

Association of antihistamines and cortancyl

Levocetirizine Oral Tablet DRUG

Levocetirizine Oral Tablet 5 mg

Antihistamines + placebo of cortancyl; Association of antihistamines and cortancyl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Louis MOURIER

Colombes, Île-de-France Region, 92700, France

Location

Related Publications (1)

• 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.

  PMID: 31439599 DERIVED

MeSH Terms

Conditions

Urticaria

Interventions

Prednisone; levocetirizine

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Nicolas JAVAUD, M.D,Ph.D

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: June 4, 2018
• Study Start: September 21, 2019
• Primary Completion: February 28, 2025
• Study Completion: September 17, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

FR (1)