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Long-term safety of fluticasone furoate nasal spray in adults and adolescents with perennial allergic rhinitis
Background: Fluticasone furoate is a novel-enhanced affinity glucocorticoid and its long-term safety must be assessed.
This study was designed to assess the safety and tolerability of 12-month intranasal administration of fluticasone furoate in adult and adolescent patients with perennial allergic rhinitis (PAR).
Methods: In this randomized, double-blind, placebo-controlled, parallel-group study, 806 patients with PAR were randomized to once daily (od) fluticasone furoate nasal spray 110 microg (n = 605) or vehicle placebo nasal spray (n = 201) for 12 months, following a 7- to 14-day screening period.
Safety was assessed by monitoring adverse events (AEs), 24-h urinary cortisol excretion, nasal and ophthalmic examinations, electrocardiograms and clinical laboratory tests.
Is flonase a steroidPlasma concentrations of fluticasone furoate were determined from blood samples.
Results: Fluticasone furoate was well tolerated. The incidence of most AEs was similar to that observed
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