Lack of effect on adult and adolescent hypothalamic-pituitary-adrenal axis function with use of fluticasone furoate nasal spray.
BACKGROUND
Intranasal corticosteroids are recommended as first-line therapy for allergic rhinitis (AR), and because of their pharmacologic class, hypothalamic-pituitary-adrenal (HPA) axis function is evaluated.


OBJECTIVE
To evaluate whether cortisol production was suppressed (as a measure of HPA axis function) by 6 weeks of treatment with fluticasone furoate nasal spray, 110 microg once daily, in patients with perennial AR.


METHODS
A double-blind, randomized, placebo- and active-controlled (prednisone), parallel-group study. Outpatients aged 12 to 65 years with perennial AR for 2 years or more were from 1 center in the United States and 1 center in Canada. Pharmacodynamic and pharmacokinetic samples were collected during 24-hour domiciled visits (overnight in clinic). Measurements included change from baseline in 24-hour serum cortisol weighted mean and 24-hour urinary free cortisol excretion, total 24-hour urinary free cortisol excretion and 6-beta hydroxycortisol excretion, and plasma concentration of fluticasone furoate.


RESULTS
A total of 112 of 183 patients were randomized. Fluticasone furoate was noninferior to placebo with respect to the ratio from baseline in serum cortisol weighted mean (treatment ratio, 0.98; 95% confidence interval, 0.89 to 1.07). In contrast, use of prednisone, 10 mg once daily, significantly reduced the ratio from baseline compared with placebo. Change from baseline in 24-hour urinary cortisol excretion was similar in the fluticasone furoate and placebo groups. Plasma levels of fluticasone furoate were undetectable after 6 weeks of treatment.


CONCLUSIONS
Fluticasone furoate nasal spray, 110 microg once daily, was not associated with HPA axis suppression in patients 12 years and older with perennial AR.
Allied Research International Inc, Mississauga, Ontario, Canada. DPatel@allied-research.com
Deepen
D
Patel
Paul
P
Ratner
Diane
D
Clements
Wei
W
Wu
Melissa
M
Faris
Edward
E
Philpot
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000730:Androstadienes / Q000097:blood / Q000494:pharmacology* / Q000627:therapeutic use; D018926:Anti-Allergic Agents / Q000097:blood / Q000494:pharmacology / Q000627:therapeutic use; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000031:analogs & derivatives / Q000097:blood / Q000652:urine; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010913:Pituitary-Adrenal System / Q000187:drug effects*; D011239:Prednisolone / Q000008:administration & dosage / Q000494:pharmacology; D012221:Rhinitis, Allergic, Perennial / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome
D000730:Androstadienes; D018926:Anti-Allergic Agents; C001380:6 beta-hydroxycortisol; D011239:Prednisolone; C523187:fluticasone furoate; D006854:Hydrocortisone