Effects of budesonide inhalation suspension on hypothalamic-pituitary-adrenal-axis function in infants and young children with persistent asthma.
BACKGROUND
The initial 12-week, double-blind phases of three studies demonstrated that budesonide inhalation suspension (BIS) is effective and well tolerated in infants and young children (6 months to 8 years of age) with persistent asthma.


OBJECTIVE
Open-label, 52-week extensions to these studies were conducted to evaluate long-term safety of BIS, including effects of treatment with the lowest effective dose of BIS on hypothalamic-pituitary-adrenal (HPA)-axis function, as compared with conventional asthma therapy (CAT). Complete results of the earlier phases of the studies and of long-term safety are reported elsewhere; only results pertaining to HPA-axis function are summarized here.


METHODS
Patients eligible for the open-label phases of the three trials were randomized to treatment with nebulized BIS (n = 447) or CAT (n = 223). CAT included short-acting oral or inhaled beta2-agonists, methylxanthines, or cromolyn sodium; in two of the studies, CAT could have included other inhaled corticosteroids. HPA-axis function, which had been evaluated during the 12-week double-blind studies, was again evaluated at the beginning and end of the 52-week study period using basal plasma cortisol concentrations and response to stimulation with a 250-microg dose of adrenocorticotropic hormone.


RESULTS
There was no evidence of altered HPA-axis function attributable to BIS treatment. No clinically or statistically significant differences in basal or adrenocorticotropic hormone-stimulated plasma cortisol concentrations were observed between BIS and CAT in either the 12-week, double-blind or 52-week, open-label phases of the three studies.


CONCLUSIONS
The results indicate that treatment with BIS does not result in clinically significant suppression of HPA-axis function in infants and young children.
Irani
Anne-Marie
AM
Department of Pediatrics, Virginia Commonwealth University, Richmond 23298-0225, USA. airani@hsc.vcu.edu
Cruz-Rivera
Mario
M
Fitzpatrick
Sherahe
S
Hoag
Julie
J
Smith
Joseph A
JA
D000280:Administration, Inhalation; D000324:Adrenocorticotropic Hormone / Q000494:pharmacology; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D019819:Budesonide / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects* / Q000503:physiopathology; D007223:Infant; D008297:Male; D010913:Pituitary-Adrenal System / Q000187:drug effects* / Q000503:physiopathology; D013535:Suspensions
D000893:Anti-Inflammatory Agents; D013535:Suspensions; D019819:Budesonide; D000324:Adrenocorticotropic Hormone