Fluticasone furoate nasal spray: a single treatment option for the symptoms of seasonal allergic rhinitis.
BACKGROUND
Fluticasone furoate (USAN-approved name) is a novel, enhanced-affinity glucocorticoid administered in a unique side-actuated device for the management of seasonal allergic rhinitis (SAR).


OBJECTIVE
We sought to evaluate the efficacy and safety of once-daily fluticasone furoate nasal spray, 110 microg, in patients aged 12 years or older with fall SAR.


METHODS
Patients (n = 299) received fluticasone furoate or placebo for 2 weeks in this double-blind, parallel-group randomized study. Patients evaluated nasal and ocular symptoms using a 4-point categoric scale. Efficacy was assessed on the basis of the mean change from baseline in reflective and instantaneous total nasal symptom scores and reflective total ocular symptom scores.


RESULTS
Fluticasone furoate produced significantly greater improvements than placebo in daily reflective total nasal symptom score (-1.473, P < .001; primary end point), morning predose instantaneous total nasal symptom score (-1.375, P < .001), daily reflective total ocular symptom score (-0.600, P = .004), and patient-rated overall response to therapy (P < .001). The onset of therapeutic effect occurred at 8 hours after initial administration. Fluticasone furoate was well tolerated.


CONCLUSIONS
Fluticasone furoate, 110 microg once daily, was effective and well tolerated for the treatment of nasal symptoms of SAR in patients aged 12 years and older. Treatment also produced significant improvements in ocular symptoms. Fluticasone furoate was fast acting, as indicated by an 8-hour onset of action, and provided 24-hour symptom control.


CONCLUSIONS
New treatments for the bothersome symptoms of SAR are needed. One such treatment, fluticasone furoate nasal spray, provides effective relief of the symptom profile of SAR.
Kaiser
Harold B
HB
Clinical Research Institute, Minneapolis, MN 55402, USA. hbk@allergy-asthma-docs.com
Naclerio
Robert M
RM
Given
John
J
Toler
Tom N
TN
Ellsworth
Anna
A
Philpot
Edward E
EE
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D031164:Ambrosia / Q000009:adverse effects / Q000276:immunology; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D004306:Dose-Response Relationship, Immunologic; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D008875:Middle Aged; D011058:Pollen / Q000009:adverse effects / Q000276:immunology; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*
D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D000068298:Fluticasone