Glucocorticoids for acute urticaria: study protocol for a double-blind non-inferiority randomised controlled trial

INTRODUCTION: This study protocol describes a trial designed to investigate whether antihistamine alone in patients with acute urticaria does not increase the 7-day Urticaria Activity Score (UAS7) in comparison with an association of antihistamine and glucocorticoids and reduces short-term relapses and chronic-induced urticaria. METHODS AND ANALYSIS: This is a prospective, double-blind, parallel-group, multicentre non-inferiority randomised controlled trial. Two-hundred and forty patients with acute urticaria admitted to emergency department will be randomised in a 1:1 ratio to receive levocetirizine or an association of levocetirizine and prednisone. Randomisation will be stratified by centre. The primary outcome will be the UAS7 at day 7. The secondary outcomes will encompass recurrence of hives and/or itch at day 7; occurrence of spontaneous hives or itch for >6 weeks; patients with angioedema at day 7, and 2, 6, 12 and 24 weeks; new emergency visits for acute urticaria recurrences at days 7 and 14, and 3 months; Dermatology Life Quality Index at days 7 and 14, and 3 and 6 months; and Chronic Urticaria Quality of Life Questionnaire at 6 weeks. ETHICS AND DISSEMINATION: The protocol has been approved by the and will be carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. A steering committee will oversee the progress of the study. Findings will be disseminated through national and international scientific conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03545464

Trials

BACKGROUND: Recent data suggest that 10-20% of injury patients will suffer for several months after the event from diverse symptoms, generally referred to as post-concussion-like symptoms (PCLS), which will lead to a decline in quality of life. A preliminary randomized control trial suggested that this condition may be induced by the stress experienced during the event or emergency room (ER) stay and can be prevented in up to 75% of patients with a single, early, short eye movement desensitization and reprocessing (EMDR) psychotherapeutic session delivered in the ER. The protocol of the SOFTER 3 study was designed to compare the impact on 3-month PCLS of early EMDR intervention and usual care in patients presenting at the ER. Secondary outcomes included 3-month post-traumatic stress disorder, 12-month PCLS, self-reported stress at the ER, self-assessed recovery expectation at discharge and 3 months, and self-reported chronic pain at discharge and 3 months. METHODS: This is a two-group, open-label, multicenter, comparative, randomized controlled trial with 3- and 12-month phone follow-up for reports of persisting symptoms (PCLS and post-traumatic stress disorder). Those eligible for inclusion were adults (>/=18 years old) presenting at the ER departments of the University Hospital of Bordeaux and University Hospital of Lyon, assessed as being at high risk of PCLS using a three-item scoring rule. The intervention groups were a (1) EMDR Recent Traumatic Episode Protocol intervention performed by a trained psychologist during ER stay or (2) usual care. The number of patients to be enrolled in each group was 223 to evidence a 15% decrease in PCLS prevalence in the EMDR group. DISCUSSION: In 2012, the year of the last national survey in France, 10.6 million people attended the ER, some of whom did so several times since 18 million visits were recorded in the same year. The SOFTER 3 study therefore addresses a major public health challenge. TRIAL REGISTRATION: Clinical Trials. NCT03400813 . Registered 17 January 2018 - retrospectively registered