Document Detail

Safety of mometasone furoate nasal spray in the treatment of nasal polyps in children.
MedLine Citation:
PMID:  23331528     Owner:  NLM     Status:  In-Data-Review    
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.
Victor Chur; Catherine B Small; Paul Stryszak; Ariel Teper
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology     Volume:  24     ISSN:  1399-3038     ISO Abbreviation:  Pediatr Allergy Immunol     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-01-21     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9106718     Medline TA:  Pediatr Allergy Immunol     Country:  England    
Other Details:
Languages:  eng     Pagination:  33-8     Citation Subset:  IM    
Copyright Information:
© 2012 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.
Instituto de Alergias y Enfermedades Respiratorias, Guatemala City, Guatemala.
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