{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T08:42:25Z","timestamp":1761986545194,"version":"3.40.5"},"reference-count":29,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2020,5,22]],"date-time":"2020-05-22T00:00:00Z","timestamp":1590105600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Optinose US, Inc."}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int Forum Allergy Rhinol"],"published-print":{"date-parts":[[2020,7]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Chronic rhinosinusitis with or without nasal polyps (CRSwNP\/CRSsNP) seriously impairs health\u2010related quality of life (HRQoL). This analysis describes the impact of the exhalation delivery system with fluticasone (EDS\u2010FLU) on HRQoL, assessed by the 36\u2010item Short\u2010Form Health Survey version 2 (SF\u201036v2), and on utilities, assessed via the Short\u2010Form 6\u2010Dimension (SF\u20106D), in patients with CRSwNP.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Post hoc analysis of pooled randomized clinical trial data (NAVIGATE I and II; N = 643) to examine change from baseline in SF\u201036v2 and SF\u20106D at end\u2010of\u2010double\u2010blind (EODB: 16 weeks) and end\u2010of\u2010open\u2010label (EOOL: 24 weeks; following 8 weeks of open\u2010label treatment) for EDS\u2010FLU vs placebo (EDS\u2010PBO). Baseline characteristics predictive of change in SF\u201036 and SF\u20106D scores were assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Mean baseline SF\u201036v2 scores were below population norms. At EODB, mean improvement was greater for all SF\u201036v2 domain and component scores with EDS\u2010FLU (range: 2.9 [physical functioning] to 5.11 [bodily pain {BP}]) vs EDS\u2010PBO (range: 0.81 [mental health] to 2.87 [BP]) (each comparison <jats:italic>p<\/jats:italic> &lt; 0.01); physical and mental component score improvements within the EDS\u2010FLU group exceeded the minimal clinically important difference (MCID). Clinically meaningful and statistically significant improvements in SF\u20106D utility scores were seen in EDS\u2010FLU\u2013treated patients compared to EDS\u2010PBO\u2013treated patients (0.058 vs 0.023, respectively, <jats:italic>p<\/jats:italic> &lt; 0.001). At EOOL, SF\u201036v2 and SF\u20106D mean scores were at or above population norms, with clinically meaningful and statistically significant improvements from baseline.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In this pooled analysis of 2 large pivotal EDS\u2010FLU trials, health domain and health utilities improvements were significantly greater with EDS\u2010FLU than EDS\u2010PBO and were comparable to population norms.<\/jats:p><\/jats:sec>","DOI":"10.1002\/alr.22573","type":"journal-article","created":{"date-parts":[[2020,5,23]],"date-time":"2020-05-23T02:43:57Z","timestamp":1590201837000},"page":"848-855","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Exhalation delivery system with fluticasone improves quality of life and health status: pooled analysis of phase 3 trials NAVIGATE I and II"],"prefix":"10.1002","volume":"10","author":[{"given":"Zachary M.","family":"Soler","sequence":"first","affiliation":[{"name":"Division of Rhinology and Sinus Surgery, Department of Otolaryngology\u2013Head and Neck Surgery Medical University of South Carolina  Charleston SC"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sam","family":"Colman","sequence":"additional","affiliation":[{"name":"OptiNose US, Inc.  Yardley PA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9054-5933","authenticated-orcid":false,"given":"Fulton F.","family":"Velez","sequence":"additional","affiliation":[{"name":"Covance Market Access Services Inc  Gaithersburg MD"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rodney J.","family":"Schlosser","sequence":"additional","affiliation":[{"name":"Division of Rhinology and Sinus Surgery, Department of Otolaryngology\u2013Head and Neck Surgery Medical University of South Carolina  Charleston SC"},{"name":"Department of Surgery Ralph H. Johnson VA Medical Center  Charleston SC"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,5,22]]},"reference":[{"key":"e_1_2_7_2_1","first-page":"1","article-title":"A cross\u2010sectional population\u2010based survey of US adults with symptoms of chronic rhinosinusitis","volume":"39","author":"Palmer JN","year":"2018","journal-title":"Allergy Asthma Proc"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2015.08.037"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.27852"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2013.07.009"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.24040"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.2500\/ajra.2016.30.4343"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.25180"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.24630"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1023494025748"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.21847"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2005.00725.x"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/alr.21556"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1008836922089"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0194-5998(95)70152-4"},{"key":"e_1_2_7_16_1","first-page":"305","article-title":"Impact of chronic rhinosinusitis therapy on quality of life; a prospective randomized controlled trial","volume":"48","author":"Ragab SM","year":"2010","journal-title":"Rhinology"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.4168\/aair.2015.7.6.534"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/alr.21695_c"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13346-012-0108-9"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.20653"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.24135"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.26391"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.5935\/1808-8694.20130055"},{"key":"e_1_2_7_24_1","unstructured":"OptiNose US Inc 2017 OptiNose US Inc. 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