Safety and efficacy of fluticasone furoate in pediatric patients with perennial allergic rhinitis.
OBJECTIVE
To evaluate the safety and efficacy of once-daily (QD) fluticasone furoate (FF) nasal spray in children with perennial allergic rhinitis (PAR).


METHODS
A global, randomized, double-blind, placebo-controlled study.


METHODS
Pediatric patients (aged 2-11 years; n = 558) with PAR received once-daily placebo, FF 110 microg, or FF 55 microg for 12 weeks. Efficacy was evaluated by nasal symptom scores. General safety and corticosteroid-specific safety (nasal and ophthalmic examinations, and hypothalamic-pituitary-adrenal assessments) were assessed.


RESULTS
No findings of clinical concern were identified from the safety assessments. For primary efficacy analysis of mean change from baseline over the first 4 weeks of treatment in daily reflective total nasal symptom score, FF 55 microg demonstrated significant improvement (P = 0.003) compared with placebo; however, the improvement for FF 110 microg versus placebo did not reach statistical significance (P = 0.073).


CONCLUSIONS
FF QD was well tolerated and demonstrated efficacy in children aged 2 to 11 years with PAR.
Máspero
Jorge F
JF
Fundacion CIDEA, Allergy and Respiratory Research Unit, Buenos Aires, Argentina. maspero@ciudad.com.ar
Rosenblut
Andres
A
Finn
Albert
A
Lim
Junghee
J
Wu
Wei
W
Philpot
Edward
E
D000284:Administration, Oral; D000730:Androstadienes / Q000008:administration & dosage* / Q000493:pharmacokinetics; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D012221:Rhinitis, Allergic, Perennial / Q000097:blood / Q000188:drug therapy*; D016896:Treatment Outcome
D000730:Androstadienes; D018926:Anti-Allergic Agents; D000068298:Fluticasone