title: Effect of therapeutic doses of mometasone furoate on cortisol levels in children with mild asthma.
abstract: Corticosteroids are the foundation of pharmacologic treatment for children with asthma. However, high-dose inhaled corticosteroid treatment can cause hypothalamic-pituitary-adrenal (HPA) axis suppression. We investigated the effect of three doses of mometasone furoate administered via dry-powder inhaler (MF-DPI) on the HPA axis in children. Fifty children (6-11 years) with mild asthma of > or =6 months' duration were randomized to MF-DPI, 100 (n = 13), 200 (n = 13), or 400 micrograms b.i.d. (n = 12), or placebo (n = 12) for 29 days. The primary end point was change from baseline in the 12-hour area under the plasma-cortisol-concentration-time curve (AUC). Secondary parameters included plasma cortisol response to cosyntropin stimulation and 24-hour urinary free cortisol concentrations. Compared with placebo, AUC changes associated with treatments of MF-DPI, 100 or 200 micrograms b.i.d., were not significant, whereas a significant change was observed with MF-DPI, 400 micrograms b.i.d. (27%; p = 0.05). Responses to cosyntropin stimulation and urinary cortisol measurements were similar to placebo with all MF-DPI doses. All regimens were well tolerated. MF-DPI did not have a significant effect on plasma or urinary cortisol levels at doses up to 200 micrograms b.i.d. in children with mild asthma. Higher MF-DPI doses may potentially suppress the HPA axis.
authors.affiliation: Allegheny General Hospital, 320 East North Avenue, Pittsburgh, PA 15212, USA. dskoner@wpahs.org
authors.forename: David P
authors.initials: DP
authors.lastname: Skoner
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Gentile
authors.forename: Betty
authors.initials: B
authors.lastname: Angelini
mesh_terms: D000280:Administration, Inhalation; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D019540:Area Under Curve; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D004334:Drug Administration Schedule; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D006854:Hydrocortisone / Q000097:blood* / Q000652:urine*; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects; D008297:Male; D000068656:Mometasone Furoate; D010913:Pituitary-Adrenal System / Q000187:drug effects; D011244:Pregnadienediols / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D018927:Anti-Asthmatic Agents; D011244:Pregnadienediols; D000068656:Mometasone Furoate; D006854:Hydrocortisone