Once-daily treatment with beclomethasone dipropionate nasal aerosol does not affect hypothalamic-pituitary-adrenal axis function.
BACKGROUND
Intranasal corticosteroids are effective in controlling allergic rhinitis (AR) symptoms; however, chronic administration of corticosteroids may suppress hypothalamic-pituitary-adrenal (HPA)-axis function.


OBJECTIVE
To evaluate the effects of 6 weeks of treatment with beclomethasone dipropionate (BDP) hydrofluoroalkane nasal aerosol on HPA-axis function in subjects with perennial AR (PAR).


METHODS
In this randomized, double-blind, placebo- and active-controlled study, subjects aged 12 to 45 years were randomized to receive BDP nasal aerosol 320 μg/day (n = 50), placebo (n = 46), or placebo/prednisone (prednisone 10 mg/day for the last 7 days of the treatment period [n = 11]). The primary end point was change from baseline in 24-hour serum cortisol (SC) weighted mean (expressed as geometric mean ratio [GMR]) in the BDP and placebo group after 6 weeks of treatment.


RESULTS
Geometric SC-weighted mean values were similar in the BDP and placebo groups at baseline (9.04 and 8.45 μg/dL, respectively) and after 6 weeks (8.18 and 8.01 μg/dL, respectively). After 6 weeks of treatment, BDP was noninferior to placebo with respect to the ratio from baseline in SC-weighted mean (GMR: 0.96 [95% CI: 0.87, 1.06]). In contrast, 7 days of prednisone treatment substantially reduced geometric SC-weighted mean values from baseline (approximate 3-fold reduction [from 7.33 to 2.31 μg/dL]) compared with placebo. BDP nasal aerosol was well tolerated, and the safety profile was similar to that of placebo.


CONCLUSIONS
Treatment with BDP nasal aerosol, 320 μg once daily, was not associated with HPA-axis suppression in adolescent and adult subjects with PAR.


BACKGROUND
Clinicaltrials.gov Identifier: NCT01133626.
Sylvana Research Associates, San Antonio, Texas 78229, USA. pratner@sylvanaresearch.com
Paul H
PH
Ratner
S David
SD
Miller
Frank C
FC
Hampel
Amy
A
Melchior
Stephanie A
SA
Dunbar
Sudeesh K
SK
Tantry
D000293:Adolescent; D000328:Adult; D000336:Aerosols; D001507:Beclomethasone / Q000008:administration & dosage* / Q000627:therapeutic use; D002648:Child; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects / Q000502:physiology*; D008875:Middle Aged; D059085:Nasal Sprays; D010913:Pituitary-Adrenal System / Q000187:drug effects / Q000502:physiology*; D010919:Placebos; D055815:Young Adult
D000336:Aerosols; D059085:Nasal Sprays; D010919:Placebos; D001507:Beclomethasone