@entity10438 nasal spray in the treatment of @entity1412 in Chinese XXXX : a double-blind, randomized, placebo-controlled trial.

@entity1 @entity137 @entity5353 @entity1412 @entity10438
BACKGROUND: Although @entity10438 nasal spray (MFNS) has demonstrated efficacy in @entity1412 ( @entity1412 ) in Western populations, data in Asian populations is limited. METHODS: This randomized, double-blind study evaluated MFNS 200  g twice per day ( @entity5353 ) vs placebo in Chinese adults with bilateral nasal polyps (graded as 1, 2, or 3 by the investigator). A 14-day placebo run-in period was followed by a 16-week treatment period with MFNS 200  g @entity5353 vs placebo (1:1 ratio). The co-primary endpoints were change from baseline in nasal congestion/obstruction averaged over the first 4 weeks of treatment and change from baseline in the total polyp size score (sum of scores from the left and right nasal fossa) at week 16. Secondary endpoints included other sinonasal symptoms scores and safety outcomes such as monitoring laboratory measurements, vital signs, and adverse events (AEs). RESULTS: There were 748 @entity1 randomized, 375 received MFNS 200  g @entity5353 and 373 received placebo. The between-treatment difference in least squares (LS) mean change from baseline in nasal congestion/obstruction over 4 weeks of treatment was -0.14 (95% confidence interval [CI], -0.22 to -0.06) for MFNS vs placebo (p = 0.0007). The between-treatment difference in LS mean change from baseline in total polyp size score at week 16 was -0.30 (95% CI, -0.45 to -0.15) for MFNS vs placebo (p < 0.0001). Serious AEs were rare (0.5% and 0.8% in MFNS and placebo groups, respectively) and considered not drug-related. There were significantly more @entity137 with MFNS vs placebo (p = 0.009). CONCLUSION: This study demonstrated that MFNS was effective and well tolerated in this population of adult, Chinese @entity1 with @entity1412 .
