EXHANCE-3: a cohort study of the exhalation delivery system with fluticasone for chronic sinusitis with or without nasal polyps.

Published on Dec 1, 2019in Rhinology3.681
路 DOI :10.4193/RHIN19.124
M.R. Sher1
Estimated H-index: 1
,
G.C. Steven1
Estimated H-index: 1
+ 6 AuthorsP.G. Djupesland1
Estimated H-index: 1
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Abstract
BACKGROUND: Inhaled nasal corticosteroid sprays (INS) are often inadequate to treat chronic rhinosinusitis (CRS). The exhalation delivery system with fluticasone (EDS-FLU; XHANCE(R)) may improve outcomes in CRS by increasing medication delivery to target superior/posterior anatomic sites. This study assessed safety and efficacy of EDS-FLU in a large population with moderate-to-severe CRS with or without nasal polyps (CRSwNP, CRSsNP). METHODS: Prospective, multicenter, 12-week, single-arm study of EDS-FLU 372 A#181;g twice daily (BID) at 38 U.S. sites. Safety was assessed by adverse-event evaluations, nasal endoscopy, and ocular examinations. Efficacy was serially assessed by outcomes including nasal endoscopy (Lund-Kennedy Score, polyp grade), patient- and physician-reported outcomes (22-item Sinonasal Outcome Test [SNOT-22]), study-defined surgical indicator assessment, and Patient Global Impression of Change (PGIC). RESULTS: 705 comparatively refractory subjects were enrolled, 603 CRSsNP and 102 CRSwNP [moderate-to-severely symptomatic; baseline SNOT-22 ~43, high rates of prior INS use (92.3%) and/or prior surgery (27.5%)]. More than 90% reported improvement on treatment by PGIC. SNOT-22 scores improved substantially and similarly in patients with NP (-23.7) and without NP (-24.4). Among patients with baseline Lund-Kennedy edema scores >0, 33.3% (CRSwNP) and 54.8% (CRSsNP) had complete resolution of edema. In CRSwNP patients, 48% had polyp elimination in ?1 nostril, 63% had ?1-point improvement in polyp grade, mean bilateral polyp grade decreased from 2.9 to 1.6, and study-defined surgical eligibility decreased. EDS-FLU was generally well tolerated, with a safety profile similar to conventional INS sprays when used to treat CRS CONCLUSION: EDS-FLU 372 #181;g BID in the treatment of CRS with or without polyps was safe, well-tolerated, and produced substantial improvement across a broad range of both objective and subjective measures.
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#1Dawei Wu (Capital Medical University)H-Index: 7
#2Tianhao Huang (Capital Medical University)H-Index: 1
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BackgroundNasal sprays with corticosteroids deliver medication to the restricted areas including anterior and inferior parts of the nasal cavity. The fluticasone exhalation delivery system (EDS-FLU...
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#1Luis Macias-Valle (Universidad La Salle)H-Index: 6
#2Alkis J. Psaltis (University of Adelaide)H-Index: 33
Objective:The purpose of this scholarly review is to present an update of the efficacy, safety, and distribution of intranasal corticosteroids (INCS) in the context of treatment for chronic rhinosi...
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#1Alexander J. Kovacs (UCI: University of California, Irvine)H-Index: 2
#2Nithin D. Adappa (UPenn: University of Pennsylvania)H-Index: 33
Last. Edward C. Kuan (UCI: University of California, Irvine)H-Index: 19
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Background:Chronic rhinosinusitis (CRS) is a common sinonasal disorder which results in significant inflammation in the nasal cavity and paranasal sinuses. Topical nasal steroids play an important ...
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PURPOSE OF REVIEW Chronic rhinosinusitis (CRS) is a prevalent condition that poses a significant burden on both quality of life and healthcare utilization. Notwithstanding the heterogenous nature of CRS endotypes and phenotypes, isotonic saline and corticosteroids are recommended as first line medical therapy by recent clinical guidelines. We provide an overview of recent studies of topical saline and corticosteroids for people with CRS and emphasize areas of unmet needs. RECENT FINDINGS Recent ...
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#1David Ranford (Guy's and St Thomas' NHS Foundation Trust)H-Index: 2
#2Claire Hopkins (Guy's and St Thomas' NHS Foundation Trust)H-Index: 55
INTRODUCTION Chronic rhinosinusitis is a common condition characterised by inflammation of the nasal and sinus linings, rhinorrhoea, nasal blockage, facial pain and loss of sense of smell for longer than 12 weeks. CRS can occur with or without nasal polyps.Areas covered: First line treatment in chronic rhinosinusitis with nasal polyps is long-term intranasal corticosteroids, which have few adverse events associated with their use, as second-generation intranasal corticosteroids having a bioavail...
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#1Xinni XuH-Index: 2
#2Sietze Reitsma (UvA: University of Amsterdam)H-Index: 12
Last. Wytske J. Fokkens (UvA: University of Amsterdam)H-Index: 64
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Chronic rhinosinusitis (CRS) is a complex upper airway inflammatory disease with a broad spectrum of clinical variants. As our understanding of the disease pathophysiology evolves, so too does our philosophy towards the approach and management of CRS. Endotyping is gaining favour over phenotype-based classifications, owing to its potential in prognosticating disease severity and delivering precision treatment. Endotyping is especially useful in challenging CRS with nasal polyposis cases, for who...
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#1Brent A. Senior (UNC: University of North Carolina at Chapel Hill)H-Index: 36
#2Rodney J. Schlosser (MUSC: Medical University of South Carolina)H-Index: 58
Last. Zachary M. Soler (MUSC: Medical University of South Carolina)H-Index: 39
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Background Standard nasal steroid sprays are often first-line treatment for chronic rhinosinusitis (CRS), but many patients remain symptomatic despite their use. The exhalation delivery system with fluticasone (EDS-FLU) has been shown to be efficacious in mixed populations of symptomatic patients, but the question remains whether benefits would be similar in those already on traditional steroid sprays. The goal of this study was to compare EDS-FLU treatment outcomes in patients who have previous...
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INTRODUCTION Chronic rhinosinusitis with nasal polyps (CRSwNP) affects 1-2.5% of the population and is associated with significant adverse effects on quality of life (QoL). CRSwNP is strongly correlated with (late onset) asthma with 30-70% of the CRSwNP patients having asthma. Health care spending in rhinosinusitis is high especially because of indirect costs. AREAS COVERED In the last years, the recognition of endotyping as an essential presumption to precision medicine has significantly change...
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I. Executive summary BACKGROUND: The 5 years since the publication of the first International Consensus Statement on Allergy and Rhinology: Rhinosinusitis (ICAR-RS) has witnessed foundational progress in our understanding and treatment of rhinologic disease. These advances are reflected within the more than 40 new topics covered within the ICAR-RS-2021 as well as updates to the original 140 topics. This executive summary consolidates the evidence-based findings of the document. Methods ICAR-RS p...
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