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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Oral Tablet | Drug | Placebo of cortancyl Oral Tablet 20mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of hives at day 7 and/or recurrence of itch at day 7 | 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. | For 7 day |
| Occurrence of spontaneous wheals and/or itch for > 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas JAVAUD, M.D,Ph.D | France Hospital Louis MOURIER Colombes, Ile De France, France, 92700 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Louis MOURIER | Colombes | Île-de-France Region | 92700 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31439599 | Derived | 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. |
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| ID | Term |
|---|---|
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| C472067 | levocetirizine |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Cortancyl Oral Tablet |
| Drug |
Cortancyl oral Tablet 20 mg |
|
| Levocetirizine Oral Tablet | Drug | Levocetirizine Oral Tablet 5 mg |
|
wheals and/or itch for > 6 weeks |
| beyond 6 Weeks |
| Patients with angioedema at day 7, 14 and 3 months | angioedema | 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 | emergency visits | up to 3 month |
| (DLQI) up to 6 months | The DLQI is a dermatology-specific quality of life questionnaire designed for use in patients over 16 years of age | up to 6 months |
| Cu-Q2QoL up to 6 months | The CU-Q2oL (French version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being | at day 7, at day 14, at 6 week, at 3 months and 6 months |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |