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- W2040238753 abstract "RATIONALE: This study was conducted to assess the safety of mometasone furoate nasal spray (MFNS) in pediatric subjects ages 6-17 with nasal polyposis (NP). METHODS: A 4-month, multinational, double-blind (to treatment) study randomized subjects with bilateral NP to MFNS 100 mcg (ages 6-11y) or 200 mcg (ages 12-17y) QD or BID, or placebo QD or BID. Endpoints included (primary) 24-hour urinary free cortisol (UFC) change from baseline, and (key secondary) 24-hour UFC corrected for creatinine/adverse events (AEs). Additional data summaries: polyp size/nasal symptoms/sense of smell/investigator-evaluated therapeutic response (0=complete relief; 4=no relief). The study was not powered to evaluate differences in efficacy endpoints. RESULTS: 127 subjects were randomized: 6-11y/12-17y (MFNS QD, n=18/n=32; MFNS BID, n=18/n=33; placebo, n=10/n=16). Pooled baseline least squares mean (LSM) 24-hour UFC levels were 49.5 nmol/24h (MFNS QD), 39.6 nmol/24h (MFNS BID), and 49.8 nmol/24h (placebo). Respective LSM UFC changes were 1.5 nmol/24h, 11.6 nmol/24h, and -2.1 nmol/24h (P≥0.194). 24-h UFC levels corrected for creatinine also showed no significant differences (P≥0.193). No safety issues emerged. Pooled MFNS QD/MFNS BID/placebo groups demonstrated reduced polyp size (-26%/-34%/-24%), improvements in congestion (-30%/-40%/-28%), anterior rhinorrhea (-29%/-30%/-25%), and endpoint vs Week 1 therapeutic response (1.64 vs 2.76/1.25 vs 2.71/1.69 vs 3.08). CONCLUSIONS: This study confirms the safety profile of MFNS in pediatric subjects with bilateral NP. There were no effects on 24-hour UFC over 4 months at double the labeled dose. MFNS BID demonstrated numerically greater reduction in polyp size and improvement in nasal symptoms than MFNS QD or placebo." @default.
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- W2040238753 date "2010-02-01" @default.
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- W2040238753 title "Mometasone Furoate Nasal Spray is Safe for the Treatment of Nasal Polyps in Pediatric Subjects 6-17 Years of Age" @default.
- W2040238753 doi "https://doi.org/10.1016/j.jaci.2009.12.399" @default.
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