Fluticasone furoate nasal spray (FFNS) 110 lg once-daily is effective in seasonal allergic rhinitis (SAR) caused by grass pollen

Abstract

Background: Fluticasone furoate is a novel enhanced-affinity glucocorticoid with a unique combination of pharmacodynamic and physicochemical properties suitable for topical activity. This European multicentre study investigated efficacy and safety of fluticasone furoate nasal spray (FFNS) in adolescents and adults with seasonal allergic rhinitis (SAR) caused by grass pollen. Methods: Patients (n5285)(X12 years) with confirmed SAR were randomised to doubleblind treatment for 2 weeks during the peak of the grass pollen season with FFNS 110 mg once daily (n5141) or vehicle placebo nasal spray (n5144) administered in a unique sideactuated device. The primary endpoint was mean change from baseline in daily reflective total nasal symptom score (rTNSS) over a 2- week treatment period (daily rTNSS5average of morning and evening score totals for nasal congestion, nasal itching, rhinorrhea, and sneezing, each rated on a 0–3 scale [none to severe]). Key secondary endpoints included the mean change from baseline over the treatment period in morning pre-dose instantaneous total nasal symptom score (iTNSS) and patient overall evaluation of response to therapy. Safety was assessed by adverse event monitoring, clinical and physical examinations, ECG monitoring and clinical laboratory tests. [...].