title: Mometasone furoate nasal spray in the treatment of nasal polyposis in Chinese patients: a double-blind, randomized, placebo-controlled trial.
abstract: BACKGROUND
  Although mometasone furoate nasal spray (MFNS) has demonstrated efficacy in nasal polyposis (NP) in Western populations, data in Asian populations is limited.
  
  
  METHODS
  This randomized, double-blind study evaluated MFNS 200 μg twice per day (BID) 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 μg BID 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 patients randomized, 375 received MFNS 200 μg BID 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 AEs of epistaxis with MFNS vs placebo (p = 0.009).
  
  
  CONCLUSIONS
  This study demonstrated that MFNS was effective and well tolerated in this population of adult, Chinese patients with NP.
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China.|Key Laboratory of Otorhinolaryngology-Head and Neck Surgery, Ministry of Education, Capital Medical University, Beijing, China.
authors.forename: Bing
authors.initials: B
authors.lastname: Zhou
authors.affiliation: Department of Otorhinolaryngology, Sichuan Provincial People's Hospital, Chengdu, China.
authors.forename: Gang
authors.initials: G
authors.lastname: He
authors.affiliation: Department of Otorhinolaryngology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.
authors.forename: Jianping
authors.initials: J
authors.lastname: Liang
authors.affiliation: Department of Otorhinolaryngology, The First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Cheng
authors.affiliation: Merck & Co., Inc, Whitehouse Station, NJ.
authors.forename: Anish
authors.initials: A
authors.lastname: Mehta
authors.affiliation: Merck & Co., Inc, Whitehouse Station, NJ.
authors.forename: Shu
authors.initials: S
authors.lastname: Liu
authors.affiliation: Merck & Co., Inc, Whitehouse Station, NJ.
authors.forename: Wenbo
authors.initials: W
authors.lastname: Yu
authors.affiliation: Merck & Co., Inc, Whitehouse Station, NJ.
authors.forename: Zaiqi
authors.initials: Z
authors.lastname: Wang
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China.|Key Laboratory of Otorhinolaryngology-Head and Neck Surgery, Ministry of Education, Capital Medical University, Beijing, China.
authors.forename: Demin
authors.initials: D
authors.lastname: Han
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D002681:China; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate / Q000627:therapeutic use*; D009298:Nasal Polyps / Q000188:drug therapy*; D059085:Nasal Sprays; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D059085:Nasal Sprays; D000068656:Mometasone Furoate
keywords: anterior rhinorrhea; intranasal corticosteroids; mometasone furoate; nasal congestion; nasal obstruction; nasal polyps; postnasal drip; randomized controlled trial