E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adults patients with isolated acute urticaria presenting to the emergency department |
Patients adultes avec urticaire aiguë se présentant aux urgences |
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E.1.1.1 | Medical condition in easily understood language |
Acute urticaria |
urticaire aigue |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001106 |
E.1.2 | Term | Acute urticaria |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
To compare the number of urticaria recurrences at day 7, to compare the number of transition to chronic urticaria, to compare the morbidity, to compare the number of patients with angioedema, to compare the quality of life |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
future ancillary study : A study will be conducted in all randomized patients to determine the factors related to the onset of complications (hypertension, induced diabetes, gastrointestinal bleeding, and rebound effect on treatment withdrawal) at the end of the therapeutic study. We collected the patient’s demographic and clinical characteristics at the time of recruitment, and standardized data pertaining to their subsequent 6 months follow-up. The primary outcome is the rate of complications: hypertension, induced diabetes, gastrointestinal bleeding, and rebound effect on treatment withdrawal. |
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E.3 | Principal 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 |
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E.4 | Principal 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 Hypersensitivity to lactose Known Renal failure defined by creatinine clearance < 10 mL/min or cardiac failure defined by ejection fraction < 40%. Hypersensitivity to active substance, to cetirizine, to hydroxyzine and to pipérazine and excipients Contre-indication to corticotherapy: oAny live vaccine oPsychotic states still uncontrolled by treatment limiting the participant's compliance with the research oSome viruses in evolution (including hepatitis, herpes, chicken pox, shingles). oAny infectious condition |
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E.5 End points |
E.5.1 | Primary end point(s) |
7-Days Urticaria Activity Score (UAS 7) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
recurrences of heaves and/or itch at day 7, occurrence of spontaneous wheals and/or itch for > 6 weeks, the reduction of morbidity is assess by new emergency visits for acute urticaria recurrences, Dermatology Life Quality Index (DLQI), Cu-Q2oL |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
at day 7, and after 6 weeks |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 21 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |