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

• Published in: The Journal of asthma 2011-10, Vol.48 (8), p.848-859
• Main Authors: Skoner, David P., Meltzer, Eli O., Milgrom, Henry, Stryszak, Paul, Teper, Ariel, Staudinger, Heribert
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Anti-Inflammatory Agents - administration & dosage; Asthma - blood; Asthma - drug therapy; Asthma - physiopathology; Asthma - urine; Body Height - physiology; Child; Child, Preschool; Collagen Type I - urine; Drug Administration Schedule; Female; Follow-Up Studies; Growth - drug effects; height; Humans; Hydrocortisone - blood; Hydrocortisone - urine; hypothalamic-pituitary-adrenal axis; Hypothalamo-Hypophyseal System - drug effects; inhaled corticosteroid; Least-Squares Analysis; Male; Mometasone Furoate; Osteocalcin - blood; pediatric; Peptides - urine; Pituitary-Adrenal System - drug effects; Pregnadienediols - administration & dosage; Respiratory Function Tests
• ISSN: 0277-0903; 1532-4303
• DOI: 10.3109/02770903.2011.604883

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. Study design. 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.