Clinical trial NCT03545464: COrticosteroids in acUte uRticAria in emerGency dEpartment
Official title: COrticosteroids in acUte uRticAria in emerGency dEpartment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Urticaria
Angiœdema
Keywords: Acute urticaria
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 7-Days Urticaria Activity Score (UAS 7) at day 7
timeFrame: For 7 day
Secondary outcomes:
measure: Recurrence of hives at day 7 and/or recurrence of itch at day 7
timeFrame: For 7 day
measure: Occurrence of spontaneous wheals and/or itch for > 6 weeks
timeFrame: beyond 6 Weeks
measure: Patients with angioedema at day 7, 14 and 3 months
timeFrame: up to 3 month
measure: The reduction of morbidity is assessed by new emergency visits for acute urticaria recurrences at day 7, 14 and 3 months
timeFrame: up to 3 month
measure: (DLQI) up to 6 months
timeFrame: up to 6 months
measure: Cu-Q2QoL up to 6 months
timeFrame: at day 7, at day 14, at 6 week, at 3 months and 6 months
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hospital Louis MOURIER
state: Ile de France
Study officials:
affiliation: France Hospital Louis MOURIER Colombes, Ile De France, France, 92700
name: Nicolas JAVAUD, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.