PMID- 32445277
OWN - NLM
STAT- MEDLINE
DCOM- 20210929
LR  - 20211217
IS  - 2042-6984 (Electronic)
IS  - 2042-6976 (Print)
IS  - 2042-6976 (Linking)
VI  - 10
IP  - 7
DP  - 2020 Jul
TI  - Exhalation delivery system with fluticasone improves quality of life and health 
      status: pooled analysis of phase 3 trials NAVIGATE I and II.
PG  - 848-855
LID - 10.1002/alr.22573 [doi]
AB  - BACKGROUND: Chronic rhinosinusitis with or without nasal polyps (CRSwNP/CRSsNP) 
      seriously impairs health-related quality of life (HRQoL). This analysis describes 
      the impact of the exhalation delivery system with fluticasone (EDS-FLU) on HRQoL, 
      assessed by the 36-item Short-Form Health Survey version 2 (SF-36v2), and on 
      utilities, assessed via the Short-Form 6-Dimension (SF-6D), in patients with 
      CRSwNP. METHODS: Post hoc analysis of pooled randomized clinical trial data 
      (NAVIGATE I and II; N = 643) to examine change from baseline in SF-36v2 and SF-6D 
      at end-of-double-blind (EODB: 16 weeks) and end-of-open-label (EOOL: 24 weeks; 
      following 8 weeks of open-label treatment) for EDS-FLU vs placebo (EDS-PBO). 
      Baseline characteristics predictive of change in SF-36 and SF-6D scores were 
      assessed. RESULTS: Mean baseline SF-36v2 scores were below population norms. At 
      EODB, mean improvement was greater for all SF-36v2 domain and component scores 
      with EDS-FLU (range: 2.9 [physical functioning] to 5.11 [bodily pain BP]) vs 
      EDS-PBO (range: 0.81 [mental health] to 2.87 [BP]) (each comparison p < 0.01); 
      physical and mental component score improvements within the EDS-FLU group 
      exceeded the minimal clinically important difference (MCID). Clinically 
      meaningful and statistically significant improvements in SF-6D utility scores 
      were seen in EDS-FLU-treated patients compared to EDS-PBO-treated patients (0.058 
      vs 0.023, respectively, p < 0.001). At EOOL, SF-36v2 and SF-6D mean scores were 
      at or above population norms, with clinically meaningful and statistically 
      significant improvements from baseline. CONCLUSION: In this pooled analysis of 2 
      large pivotal EDS-FLU trials, health domain and health utilities improvements 
      were significantly greater with EDS-FLU than EDS-PBO and were comparable to 
      population norms.
CI  - (c) 2020 The Authors. International Forum of Allergy & Rhinology published by Wiley 
      Periodicals, Inc. on behalf of American Academy of Otolaryngic Allergy and 
      American Rhinologic Society.
FAU - Soler, Zachary M
AU  - Soler ZM
AD  - Division of Rhinology and Sinus Surgery, Department of Otolaryngology-Head and 
      Neck Surgery, Medical University of South Carolina, Charleston, SC.
FAU - Colman, Sam
AU  - Colman S
AD  - OptiNose US, Inc., Yardley, PA.
FAU - Velez, Fulton F
AU  - Velez FF
AUID- ORCID: 0000-0001-9054-5933
AD  - Covance Market Access Services Inc, Gaithersburg, MD.
FAU - Schlosser, Rodney J
AU  - Schlosser RJ
AD  - Division of Rhinology and Sinus Surgery, Department of Otolaryngology-Head and 
      Neck Surgery, Medical University of South Carolina, Charleston, SC.
AD  - Department of Surgery, Ralph H. Johnson VA Medical Center, Charleston, SC.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200522
PL  - United States
TA  - Int Forum Allergy Rhinol
JT  - International forum of allergy & rhinology
JID - 101550261
RN  - CUT2W21N7U (Fluticasone)
SB  - IM
MH  - Exhalation
MH  - Fluticasone/therapeutic use
MH  - Health Status
MH  - Humans
MH  - *Nasal Polyps
MH  - *Quality of Life
MH  - Surveys and Questionnaires
PMC - PMC7818430
OTO - NOTNLM
OT  - health status
OT  - intervention study
OT  - nasal polyps
OT  - population health
OT  - quality improvement
OT  - quality of life
EDAT- 2020/05/24 06:00
MHDA- 2021/09/30 06:00
PMCR- 2021/01/21
CRDT- 2020/05/24 06:00
PHST- 2019/09/13 00:00 [received]
PHST- 2020/02/25 00:00 [revised]
PHST- 2020/03/06 00:00 [accepted]
PHST- 2020/05/24 06:00 [pubmed]
PHST- 2021/09/30 06:00 [medline]
PHST- 2020/05/24 06:00 [entrez]
PHST- 2021/01/21 00:00 [pmc-release]
AID - ALR22573 [pii]
AID - 10.1002/alr.22573 [doi]
PST - ppublish
SO  - Int Forum Allergy Rhinol. 2020 Jul;10(7):848-855. doi: 10.1002/alr.22573. Epub 
      2020 May 22.