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Efficacy of switching to bilastine, a histamine H1 receptor antagonist, in patients with chronic spontaneous urticaria (H1-SWITCH): study protocol for a randomized controlled trial.


ABSTRACT: BACKGROUND:Chronic spontaneous urticaria (CSU) is characterized by the spontaneous appearance of wheals, angioedema, or both for > 6 weeks. Continuous treatment with H1-antihistamines is used as a first-line treatment for CSU. However, H1-antihistamine treatment leads to absence of symptoms in less than 50% of patients with CSU. Although Japanese guidelines for the diagnosis and treatment of urticaria recommend an increase in the H1-antihistamine dose or a switch to other H1-antihistamines, there is no evidence supporting a switch to other H1-antihistamines in patients with refractory CSU who are unresponsive to H1-antihistamines at the licensed dose. METHODS:We will conduct a multicenter, open-label, non-inferiority, randomized, parallel, comparison study to determine if the efficacy of b

SUBMITTER: Fukunaga A 

PROVIDER: S-EPMC6945582 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature