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COrticosteroids in acUte uRticAria in emerGency dEpartment (COURAGE)

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ClinicalTrials.gov Identifier: NCT03545464
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
To demonstrate the non-inferiority of the efficacy of a single antihistamine in comparaison with an association of antihistamine and corticosteroid in the treatment of acute urticaria in emergency departments

Condition or disease Intervention/treatment Phase
Urticaria Angiœdema Drug: Placebo Oral Tablet Drug: Cortancyl Oral Tablet Drug: Levocetirizine Oral Tablet Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: COrticosteroids in acUte uRticAria in emerGency dEpartment
Actual Study Start Date : September 21, 2019
Actual Primary Completion Date : September 28, 2021
Estimated Study Completion Date : March 21, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives Steroids

Arms and Interventions
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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: Cortancyl Oral Tablet
Cortancyl oral Tablet 20 mg

Drug: Levocetirizine Oral Tablet
Levocetirizine Oral Tablet 5 mg


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, ciclosporine 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545464


Contacts
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Contact: Nicolas JAVAUD, M.D,Ph.D +33 1 47 60 64 42 nicolas.javaud@aphp.fr
Contact: Fréderic ADNET, M.D,Ph.D +33 1 48 96 44 08 frederic.adnet@aphp.fr

Locations
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France
Hospital Louis MOURIER Recruiting
Colombes, Ile De France, France, 92700
Contact: Nicolas JAVAUD, M.D, Ph.D    +33 1 47 60 64 42    nicolas.javaud@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Nicolas JAVAUD, M.D,Ph.D France Hospital Louis MOURIER Colombes, Ile De France, France, 92700
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03545464    
Other Study ID Numbers: P160913
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute urticaria
Additional relevant MeSH terms:
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Angioedema
Urticaria
Emergencies
Disease Attributes
Pathologic Processes
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Prednisone
Levocetirizine
 Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action