title: Effects of inhaled mometasone furoate on growth velocity and adrenal function: a placebo-controlled trial in children 4-9 years old with mild persistent asthma.
abstract: OBJECTIVE
  To assess the effects of long-term mometasone furoate delivered via a dry powder inhaler (MF-DPI) on growth velocity and hypothalamic-pituitary-adrenal axis function in children with asthma.
  
  
  METHODS
  Children aged 4-9 years with asthma (n = 187) were randomized to MF-DPI 100 μg (delivered dose; actuated dose is 110 μg) once daily in the morning (QD AM), 100 μg twice daily (BID), 200 μg QD AM, or placebo for 52 weeks followed by a 3-month follow-up period. The primary outcome was growth velocity calculated from stadiometric heights recorded at each visit. Secondary outcomes included serum and 12-h urinary cortisol, serum osteocalcin, and urinary N-telopeptide.
  
  
  RESULTS
  MF-DPI 100 μg QD AM treatment did not significantly affect growth velocity compared with placebo (-0.10 ± 0.31 cm/y, p = 0.76). When the effect of a total daily dose of 200 μg MF-DPI on growth velocity was examined, no significant effect was demonstrated for MF-DPI 100 μg BID compared with placebo (-0.64 ± 0.39 cm/y, p = 0.10), although the change in mean growth velocity with MF-DPI 200 μg QD AM reached statistical significance (-0.70 ± 0.29 cm/y, p = 0.02). The effects of all examined doses of MF-DPI on mean plasma cortisol levels were similar to cortisol changes seen in the placebo group, suggesting an absence of drug-related effects. No differences in 12-h urinary cortisol or other outcomes were observed between groups.
  
  
  CONCLUSIONS
  One year of treatment with a total daily dose of 100 μg of MF-DPI in the morning resulted in no significant difference, whereas a total daily dose of 200 μg of MF-DPI was associated with some changes in growth velocity when compared with placebo. The differences in growth velocity, and the absence of drug-related cortisol effects, support the use of a total daily dose of 100 μg of MF-DPI in children aged 4-9 years with mild persistent asthma.
authors.affiliation: Allegheny General Hospital, Pittsburgh, PA 15212, USA. dskoner@wpahs.org
authors.forename: David P
authors.initials: DP
authors.lastname: Skoner
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.forename: Henry
authors.initials: H
authors.lastname: Milgrom
authors.forename: Paul
authors.initials: P
authors.lastname: Stryszak
authors.forename: Ariel
authors.initials: A
authors.lastname: Teper
authors.forename: Heribert
authors.initials: H
authors.lastname: Staudinger
mesh_terms: D000280:Administration, Inhalation; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001249:Asthma / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology / Q000652:urine; D001827:Body Height / Q000502:physiology; D002648:Child; D002675:Child, Preschool; D024042:Collagen Type I / Q000652:urine; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006128:Growth / Q000187:drug effects*; D006801:Humans; D006854:Hydrocortisone / Q000097:blood / Q000652:urine; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects*; D016018:Least-Squares Analysis; D008297:Male; D000068656:Mometasone Furoate; D015675:Osteocalcin / Q000097:blood; D010455:Peptides / Q000652:urine; D010913:Pituitary-Adrenal System / Q000187:drug effects*; D011244:Pregnadienediols / Q000008:administration & dosage*; D012129:Respiratory Function Tests
chemical_list: D000893:Anti-Inflammatory Agents; D024042:Collagen Type I; D010455:Peptides; D011244:Pregnadienediols; C052929:collagen type I trimeric cross-linked peptide; D000068656:Mometasone Furoate; D015675:Osteocalcin; D006854:Hydrocortisone