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Background: Mastocytosis is frequently associated with mast cell-mediated symp- toms which require relieving medication. While second generation antihistamines (sgAHs) are the first line therapeutic strategy to treat mast cell mediator-related symptoms, controlled clinical trials on how they improve quality of life have not been performed.

Methods: This randomized, double-blind, placebo-controlled, cross-over trial assessed rupatadine 20 mg daily in the treatment of mastocytosis symptoms in 30 adult patients. Symptoms were assessed by a visual analogue scale (VAS) and symptom specific quality of life questionnaire (ItchyQoL).

Results: The mean ItchyQoL total score and VAS symptom score were signifi- cantly improved in the rupatadine treatment phase compared with placebo. There were also significant reductions from placebo in the severity of itch, wheal and flare, flushing, tachycardia and headache but not gastrointestinal symptoms. Conclusions: In this first comprehensive trial of a sgAH in mastocytosis, rupata- dine 20 mg daily for 4 weeks significantly controlled symptoms and improved patients’ quality of life.