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OpenTrials
Completed

NCT Number: NCT03545464

COrticosteroids in acUte uRticAria in emerGency dEpartment

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Louis MOURIER

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo oral tablet

Drug

Placebo of cortancyl Oral Tablet 20mg

Cortancyl Oral Tablet

Drug

Cortancyl oral Tablet 20 mg

Levocetirizine Oral Tablet

Drug

Levocetirizine Oral Tablet 5 mg

Primary outcomes

  1. 7-Days Urticaria Activity Score (UAS 7) at day 7

    Time frame: 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 outcomes

  1. Recurrence of hives at day 7 and/or recurrence of itch at day 7

    Time frame: 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.

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

    Time frame: beyond 6 Weeks

    wheals and/or itch for > 6 weeks

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

    Time frame: up to 3 month

    angioedema

  4. The reduction of morbidity is assessed by new emergency visits for acute urticaria recurrences at day 7, 14 and 3 months

    Time frame: up to 3 month

    emergency visits

  5. (DLQI) up to 6 months

    Time frame: up to 6 months

    The DLQI is a dermatology-specific quality of life questionnaire designed for use in patients over 16 years of age

  6. Cu-Q2QoL up to 6 months

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: COURAGE

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2018
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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