title: Safety of mometasone furoate nasal spray in the treatment of nasal polyps in children.
abstract: BACKGROUND
  Mometasone furoate nasal spray (MFNS) improves nasal symptoms and reduces polyp size in adults with nasal polyposis. This 4-month, multinational, randomized, double-blind study was conducted to assess the safety of MFNS in pediatric subjects aged 6-17 yr.
  
  
  METHODS
  Subjects aged 6-11 yr with bilateral nasal polyps received MFNS 100 μg once or twice daily or placebo; those aged 12-17 yr received MFNS 200 μg once or twice daily or placebo. End-points included change in 24-h urinary free cortisol (primary), change in 24-h urinary free cortisol corrected for creatinine (key secondary), and adverse events. Efficacy parameters included polyp size, nasal symptoms, and investigator-evaluated therapeutic response, although the study was not powered for statistical analysis of efficacy.
  
  
  RESULTS
  Least squares baseline mean urinary free cortisol level (nmol/24 h) for both age groups combined (N = 127) was 49.5 in the MFNS once-daily group, 39.6 in the MFNS twice-daily group, and 49.8 in the placebo group. Change in 24-h urinary free cortisol did not significantly differ among MFNS- and placebo-treated subjects. Least squares mean 24-h urinary free cortisol levels corrected for creatinine also showed no significant differences among MFNS- and placebo-treated subjects. No safety issues emerged.
  
  
  CONCLUSIONS
  Results of this study confirm the safety profile of MFNS in pediatric patients with bilateral nasal polyps over 4 months, even at double the recommended pediatric dosage for allergic rhinitis.
authors: Instituto de Alergias y Enfermedades Respiratorias, Guatemala City, Guatemala. inaler2004@yahoo.es
authors: Victor
authors: V
authors: Chur
authors: Catherine B
authors: CB
authors: Small
authors: Paul
authors: P
authors: Stryszak
authors: Ariel
authors: A
authors: Teper
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D000068656:Mometasone Furoate; D009298:Nasal Polyps / Q000188:drug therapy*; D059085:Nasal Sprays; D011244:Pregnadienediols / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D059085:Nasal Sprays; D011244:Pregnadienediols; D000068656:Mometasone Furoate