PMID- 26575524
OWN - NLM
STAT- MEDLINE
DCOM- 20161011
LR  - 20161230
IS  - 2042-6984 (Electronic)
IS  - 2042-6976 (Linking)
VI  - 6
IP  - 1
DP  - 2016 Jan
TI  - Mometasone furoate nasal spray in the treatment of nasal polyposis in Chinese 
      patients: a double-blind, randomized, placebo-controlled trial.
PG  - 88-94
LID - 10.1002/alr.21650 [doi]
AB  - 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 mug 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 mug 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 mug 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). CONCLUSION: This study 
      demonstrated that MFNS was effective and well tolerated in this population of 
      adult, Chinese patients with NP.
CI  - (c) 2015 ARS-AAOA, LLC.
FAU - Zhou, Bing
AU  - Zhou B
AD  - Department of Otorhinolaryngology-Head and Neck Surgery, Beijing Tongren 
      Hospital, Capital Medical University, Beijing, China.
AD  - Key Laboratory of Otorhinolaryngology-Head and Neck Surgery, Ministry of 
      Education, Capital Medical University, Beijing, China.
FAU - He, Gang
AU  - He G
AD  - Department of Otorhinolaryngology, Sichuan Provincial People's Hospital, Chengdu, 
      China.
FAU - Liang, Jianping
AU  - Liang J
AD  - Department of Otorhinolaryngology, The People's Hospital of Guangxi Zhuang 
      Autonomous Region, Nanning, China.
FAU - Cheng, Lei
AU  - Cheng L
AD  - Department of Otorhinolaryngology, The First Affiliated Hospital, Nanjing Medical 
      University, Nanjing, China.
FAU - Mehta, Anish
AU  - Mehta A
AD  - Merck & Co., Inc, Whitehouse Station, NJ.
FAU - Liu, Shu
AU  - Liu S
AD  - Merck & Co., Inc, Whitehouse Station, NJ.
FAU - Yu, Wenbo
AU  - Yu W
AD  - Merck & Co., Inc, Whitehouse Station, NJ.
FAU - Wang, Zaiqi
AU  - Wang Z
AD  - Merck & Co., Inc, Whitehouse Station, NJ.
FAU - Han, Demin
AU  - Han D
AD  - Department of Otorhinolaryngology-Head and Neck Surgery, Beijing Tongren 
      Hospital, Capital Medical University, Beijing, China.
AD  - Key Laboratory of Otorhinolaryngology-Head and Neck Surgery, Ministry of 
      Education, Capital Medical University, Beijing, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT01386125
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20151117
PL  - United States
TA  - Int Forum Allergy Rhinol
JT  - International forum of allergy & rhinology
JID - 101550261
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Nasal Sprays)
RN  - 04201GDN4R (Mometasone Furoate)
SB  - IM
MH  - Administration, Intranasal
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Inflammatory Agents/*therapeutic use
MH  - China
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mometasone Furoate/*therapeutic use
MH  - Nasal Polyps/*drug therapy
MH  - *Nasal Sprays
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - anterior rhinorrhea
OT  - intranasal corticosteroids
OT  - mometasone furoate
OT  - nasal congestion
OT  - nasal obstruction
OT  - nasal polyps
OT  - postnasal drip
OT  - randomized controlled trial
EDAT- 2015/11/18 06:00
MHDA- 2016/10/12 06:00
CRDT- 2015/11/18 06:00
PHST- 2015/04/16 00:00 [received]
PHST- 2015/07/30 00:00 [revised]
PHST- 2015/08/14 00:00 [accepted]
PHST- 2015/11/18 06:00 [entrez]
PHST- 2015/11/18 06:00 [pubmed]
PHST- 2016/10/12 06:00 [medline]
AID - 10.1002/alr.21650 [doi]
PST - ppublish
SO  - Int Forum Allergy Rhinol. 2016 Jan;6(1):88-94. doi: 10.1002/alr.21650. Epub 2015 
      Nov 17.