Angiœdema, Urticaria
Conditions
Keywords
Acute urticaria
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.
Interventions
Levocetirizine Oral Tablet 5 mg
DRUGPlacebo Oral Tablet
Placebo of cortancyl Oral Tablet 20mg
DRUGCortancyl Oral Tablet
Cortancyl oral Tablet 20 mg
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-Days Urticaria Activity Score (UAS 7) at day 7 | 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
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of spontaneous wheals and/or itch for > 6 weeks | beyond 6 Weeks | wheals and/or itch for \> 6 weeks |
| Patients with angioedema at day 7, 14 and 3 months | up to 3 month | angioedema |
| Recurrence of hives at day 7 and/or recurrence of itch at day 7 | 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. |
| (DLQI) up to 6 months | up to 6 months | The DLQI is a dermatology-specific quality of life questionnaire designed for use in patients over 16 years of age |
| Cu-Q2QoL up to 6 months | 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 |
| 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 | emergency visits |
Countries
France
Outcome results
None listed