{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T20:57:07Z","timestamp":1792270627246,"version":"4.4.0"},"reference-count":30,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2024,8,26]],"date-time":"2024-08-26T00:00:00Z","timestamp":1724630400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int Forum Allergy Rhinol"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The inability of topical medications to reach sinus cavities is a potential reason for lack of efficacy in chronic rhinosinusitis (CRS). One purpose of endoscopic sinus surgery (ESS) is to enable delivery of medications into the sinus cavities. The exhalation delivery system with fluticasone (EDS\u2010FLU; XHANCE) creates unique biomechanics that enable deposition of intranasal corticosteroid into sinuses and sinus drainage pathways but may have differing efficacy in operated versus unoperated sinuses. Two 24\u2010week randomized trials (ReOpen1\/2) evaluated EDS\u2010FLU versus EDS\u2010placebo in patients with CRS, stratified by surgical status.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Surgery\u2010naive (<jats:italic>n<\/jats:italic>\u00a0=\u00a0332) and prior\u2010surgery (<jats:italic>n<\/jats:italic>\u00a0=\u00a0215) patient groups were analyzed as pooled data from ReOpen1\/2. Outcome measures (least\u2010squares mean change from baseline) included combined symptom score (CSS) and congestion score at weeks 4, 8, and 12 and average of percentages of opacified volume (APOV) of ethmoid\/maxillary sinuses on CT and Sinonasal Outcome Test 22 (SNOT\u201022) total score at week 24.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Baseline scores suggested moderate\u2013severe disease: mean CSS\u00a0=\u00a05.8; APOV\u00a0=\u00a067.2%. EDS\u2010FLU produced significant improvement versus placebo (<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.05): CSS (surgery\u2010naive, \u22120.68\u00a0vs. \u22121.42; prior ESS, \u22120.70\u00a0vs. \u22121.87); congestion (surgery\u2010naive, \u22120.24\u00a0vs. \u22120.59; prior ESS, \u22120.24\u00a0vs. \u22120.69); and SNOT\u201022 (surgery\u2010naive, \u22127.56\u00a0vs. \u221218.30; prior ESS, \u221210.72\u00a0vs. \u221218.74). Similar results were observed for APOV (<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.05). No statistically significant difference was observed between surgery subgroups with either EDS\u2010FLU dose.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>EDS\u2010FLU improved symptoms, sinus opacification, and quality of life in patients with CRS with or without prior ESS, suggesting a role for EDS\u2010FLU in both populations.<\/jats:p><\/jats:sec>","DOI":"10.1002\/alr.23434","type":"journal-article","created":{"date-parts":[[2024,8,26]],"date-time":"2024-08-26T14:58:30Z","timestamp":1724684310000},"page":"1892-1903","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["EDS\u2010FLU efficacy in patients with chronic rhinosinusitis with or without prior sinus surgery in ReOpen1 and ReOpen2 randomized controlled trials"],"prefix":"10.1002","volume":"14","author":[{"given":"Sarah K.","family":"Wise","sequence":"first","affiliation":[{"name":"Emory University School of Medicine  Atlanta Georgia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nithin D.","family":"Adappa","sequence":"additional","affiliation":[{"name":"Perelman School of Medicine University of Pennsylvania  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rakesh K.","family":"Chandra","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center  Nashville Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Greg E.","family":"Davis","sequence":"additional","affiliation":[{"name":"University of Washington  Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahboobeh","family":"Mahdavinia","sequence":"additional","affiliation":[{"name":"UTHealth Houston  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramy","family":"Mahmoud","sequence":"additional","affiliation":[{"name":"Optinose US, Inc.  Yardley Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Messina","sequence":"additional","affiliation":[{"name":"Optinose US, Inc.  Yardley Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James N.","family":"Palmer","sequence":"additional","affiliation":[{"name":"Perelman School of Medicine University of Pennsylvania  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2072-982X","authenticated-orcid":false,"given":"Zara M.","family":"Patel","sequence":"additional","affiliation":[{"name":"Stanford University School of Medicine  Stanford California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anju T.","family":"Peters","sequence":"additional","affiliation":[{"name":"Feinberg School of Medicine Northwestern University  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodney J.","family":"Schlosser","sequence":"additional","affiliation":[{"name":"Medical University of South Carolina  Charleston South Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raj","family":"Sindwani","sequence":"additional","affiliation":[{"name":"Cleveland Clinic  Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zachary M.","family":"Soler","sequence":"additional","affiliation":[{"name":"Medical University of South Carolina  Charleston South Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew A.","family":"White","sequence":"additional","affiliation":[{"name":"Scripps Clinic  San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,8,26]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41572\u2010020\u201000218\u20101"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2013.07.009"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.4193\/Rhin20.600"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/alr.22741"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.24040"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.21847"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S25199"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.anai.2022.09.008"},{"key":"e_1_2_8_10_1","unstructured":"NDA 20762.Nasonex\u00ae. 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