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. Plasma 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 with placebo, with the exception of epistaxis, which was more frequently reported on active treatment. There were no clinically meaningful differences between fluticasone furoate and placebo in terms of safety assessments, including mean changes in ophthalmic parameters and 24-h urine cortisol excretion. Plasma concentrations of fluticasone furoate were not quantifiable in the majority of patients following intranasal administration.


CONCLUSIONS
Long-term (12-month) administration of fluticasone furoate 110 microg od revealed an AE profile typical of the intranasal corticosteroid class in both adult and adolescent patients with PAR, with no evidence of clinically relevant systemic corticosteroid exposure.
Hospital Dr Sotero del Rio, Puente Alto, Santiago, Chile.
A
A
Rosenblut
P G
PG
Bardin
B
B
Muller
M A
MA
Faris
W W
WW
Wu
M F
MF
Caldwell
W J
WJ
Fokkens
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects* / Q000493:pharmacokinetics; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000493:pharmacokinetics; D002648:Child; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D006801:Humans; D006854:Hydrocortisone / Q000652:urine; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000652:urine
D000730:Androstadienes; D018926:Anti-Allergic Agents; D000068298:Fluticasone; D006854:Hydrocortisone