Effect of budesonide aqueous nasal spray on hypothalamic-pituitary-adrenal axis function in children with allergic rhinitis.
BACKGROUND
Intranasal corticosteroids are safe and effective for treating allergic rhinitis in adults. Since children may receive more systemic corticosteroid on a dose-per-weight basis than adults, the safety of corticosteroid therapy in pediatric patients is an important issue.


OBJECTIVE
To determine the effects of treatment with budesonide aqueous nasal spray using the recommended once-daily dose for adults and children 6 years and older on hypothalamic-pituitary-adrenal (HPA) axis function in pediatric patients with allergic rhinitis.


METHODS
In a 6-week, multicenter, double-blind, placebo-controlled study, 78 patients aged 2 to 5 years with allergic rhinitis were treated with budesonide aqueous nasal spray (64 microg/d) or placebo. Mean change in morning plasma cortisol levels from baseline to study end 0, 30, and 60 minutes after low-dose (10-microg) cosyntropin stimulation and mean change in the difference from 0 to 30 minutes and from 0 to 60 minutes after cosyntropin stimulation were used to evaluate HPA axis function.


RESULTS
Mean change from baseline to study end in plasma cortisol levels 0, 30, and 60 minutes after cosyntropin stimulation and the difference from 0 to 30 minutes and from 0 to 60 minutes were not significantly different between the treatment and placebo groups (P > .05 for all). At the end of the study, 3 budesonide aqueous nasal spray and 6 placebo patients were classified as having subnormal HPA axis function. The safety and tolerability profile of budesonide aqueous nasal spray was comparable to that of placebo.


CONCLUSIONS
Administration of budesonide aqueous nasal spray for 6 weeks was well tolerated and safe and had no measurable suppressive effects on HPA axis function in patients aged 2 to 5 years with allergic rhinitis.
Allergy, Asthma & Respiratory Care Medical Center, Long Beach, California 90806, USA. drkkim@wcctrials.com
Kenneth T
KT
Kim
Nathan
N
Rabinovitch
Thomas
T
Uryniak
Brandon
B
Simpson
Liza
L
O'Dowd
Frank
F
Casty
D000336:Aerosols; D019819:Budesonide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects* / Q000502:physiology; D008297:Male; D010349:Patient Compliance; D010913:Pituitary-Adrenal System / Q000187:drug effects* / Q000502:physiology; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000503:physiopathology; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology
D000336:Aerosols; D019819:Budesonide