{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:44:46Z","timestamp":1787013886863,"version":"build-2736575974"},"reference-count":41,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2024,12,16]],"date-time":"2024-12-16T00:00:00Z","timestamp":1734307200000},"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":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>EsoCap is a thin mucoadhesive film designed to target the oesophageal mucosa. The device loaded with mometasone furoate (ESO\u2010101) is under investigation for the treatment of eosinophilic oesophagitis (EoE).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To evaluate the efficacy, safety and tolerability of ESO\u2010101 in patients with active EoE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We conducted a randomised, placebo\u2010controlled, phase 2, proof\u2010of\u2010concept trial at 14 European sites in adults with EoE. Participants received placebo, uncoated EsoCap (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200915), or EsoCap loaded with 800\u2009\u03bcg of mometasone furoate (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200928) once daily during 28\u2009days. The primary outcome was the absolute change in the peak eosinophil count; secondary outcomes were histologic, clinical and endoscopic measures.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Treatment with ESO\u2010101 resulted in reduction (mean\u2009\u00b1\u2009SD) of 49.1\u2009\u00b1\u200988.4 eosinophils\/high\u2010power field from baseline, compared with 6.6\u2009\u00b1\u200965.1 with placebo (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.03). With ESO\u2010101, 48% and 44% of patients achieved &lt;\u200915 and &lt;\u20096 eosinophils\/high\u2010power field, respectively; these were 0% with placebo. EoE Endoscopic Reference Score reduced significantly in patients treated with ESO\u2010101. In contrast, dysphagia and odynophagia severity decreased similarly in both groups. There were no serious treatment\u2010emergent adverse events. Mean serum cortisol did not change significantly throughout the trial. Notably, no oropharyngeal or oesophageal candidiasis was documented. The device was well tolerated.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      ESO\u2010101 was superior to placebo in reducing oesophageal eosinophilia. The device was safe and well tolerated in adults with EoE, supporting the continued development of ESO\u2010101 for the treatment of EoE (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/trials.gov\">Trials.gov<\/jats:ext-link>\n                      No.: NCT04849390; Eu\u2010CT No.: 2020\u2013000082\u201016).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.18443","type":"journal-article","created":{"date-parts":[[2024,12,16]],"date-time":"2024-12-16T05:14:14Z","timestamp":1734326054000},"page":"444-455","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Clinical Trial: Safety and Efficacy of a Novel Oesophageal Delivery System for Topical Corticosteroids Versus Placebo in the Treatment of Eosinophilic Oesophagitis"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1183-1072","authenticated-orcid":false,"given":"Alfredo J.","family":"Lucendo","sequence":"first","affiliation":[{"name":"Department of Gastroenterology Hospital General de Tomelloso  Tomelloso Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red Enfermedades Hep\u00e1ticas y Digestivas (CIBEREHD)  Madrid Spain"},{"name":"Instituto de Investigaci\u00f3n Sanitaria de Castilla\u2010La Mancha (IDISCAM)  Toledo Spain"},{"name":"Instituto de Investigaci\u00f3n Sanitaria Princesa  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3587-1039","authenticated-orcid":false,"given":"\u00d3scar","family":"Nantes\u2010Castillejo","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Complejo Hospitalario de Navarra  Pamplona Spain"},{"name":"IdiSNA. Instituto de Investigaci\u00f3n Sanitaria de Navarra  Pamplona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1428-6404","authenticated-orcid":false,"given":"Alex","family":"Straumann","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology &amp; Hepatology Universit\u00e4ty Hospital Zurich  Zurich Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0824-4125","authenticated-orcid":false,"given":"Luc","family":"Biedermann","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology &amp; Hepatology Universit\u00e4ty Hospital Zurich  Zurich Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5918-2062","authenticated-orcid":false,"given":"Albert J.","family":"Bredenoord","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Amsterdam University Medical Center  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6171-1901","authenticated-orcid":false,"given":"Danila","family":"Guagnozzi","sequence":"additional","affiliation":[{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red Enfermedades Hep\u00e1ticas y Digestivas (CIBEREHD)  Madrid Spain"},{"name":"Department of Gastroenterology Hospital Universitario Vall d'Hebr\u00f3n  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9673-345X","authenticated-orcid":false,"given":"Leonardo","family":"Blas\u2010Jhon","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Fundaci\u00f3n Jim\u00e9nez D\u00edaz  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0826-9197","authenticated-orcid":false,"given":"Anna","family":"Wiechowska\u2010Kozlowska","sequence":"additional","affiliation":[{"name":"Endoscopy Unit Sonomed Medical Centre  Szczecin Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7193-2778","authenticated-orcid":false,"given":"Simon","family":"Weidlich","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine II, School of Medicine and Health, University Hospital Rechts der Isar Technical University of Munich  Munich Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3214-0166","authenticated-orcid":false,"given":"Ulrike","family":"von Arnim","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Infectious Diseases Universit\u00e4tsklinikum Magdeburg A\u00f6R  Magdeburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecilio","family":"Santander\u2010Vaquero","sequence":"additional","affiliation":[{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red Enfermedades Hep\u00e1ticas y Digestivas (CIBEREHD)  Madrid Spain"},{"name":"Instituto de Investigaci\u00f3n Sanitaria Princesa  Madrid Spain"},{"name":"Department of Gastroenterology Hospital Universitario de La Princesa  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4137-8790","authenticated-orcid":false,"given":"Antonia","family":"Perell\u00f3","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Hospital de Viladecans  Viladecans Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2535-1929","authenticated-orcid":false,"given":"Isabel","family":"P\u00e9rez\u2010Mart\u00ednez","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Hospital Universitario Central de Asturias  Oviedo Spain"},{"name":"Diet, Microbiota and Health Group Instituto de Investigaci\u00f3n Sanitaria del Principado de Asturias (ISPA)  Oviedo Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7087-3921","authenticated-orcid":false,"given":"Jes\u00fas","family":"Barrio","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Hospital Universitario R\u00edo Hortega. Gerencia Regional de Salud de Castilla y Le\u00f3n (SACYL)  Valladolid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4336-7721","authenticated-orcid":false,"given":"Michael","family":"Vieth","sequence":"additional","affiliation":[{"name":"Institut f\u00fcr Pathologie Friedrich\u2010Alexander\u2010Universit\u00e4t Erlangen\u2010N\u00fcrnberg, Klinikum Bayreuth  Bayreuth Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6320-8015","authenticated-orcid":false,"given":"Ghazaleh","family":"Gouya","sequence":"additional","affiliation":[{"name":"Gouya Insights  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1167-1101","authenticated-orcid":false,"given":"Evan S.","family":"Dellon","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Gastroenterology and Hepatology, School of Medicine University of North Carolina at Chapel Hill  Chapel Hill USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,12,16]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/2050640616689525"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2018.07.009"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.3390\/nu16142231"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.15957"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.02.039"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2205982"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.14123"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/ueg2.12533"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.11.021"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2019.03.014"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2019.03.025"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.07.039"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1177\/0194599811409857"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2019.08.042"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1080\/00365521.2021.1906314"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jconrel.2020.08.011"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-199855010-00009"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajd.12762"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.45.2.172"},{"key":"e_1_2_9_21_1","volume-title":"The Oesophagus, Handbook and Atlas of Endoscopy","author":"Savary M.","year":"1978"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics13060828"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2011-301817"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1080\/17474124.2017.1367664"},{"key":"e_1_2_9_25_1","first-page":"90","article-title":"Treatment of Eosinophilic Esophagitis With Inhaled Corticosteroids","volume":"27","author":"Faubion W. A.","year":"1998","journal-title":"Journal of Pediatric Gastroenterology and Nutrition"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2015.07.041"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2012.04.049"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2006.08.033"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2010.07.048"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2010.05.001"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.1002\/jpn3.12273"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.1177\/1756284820927282"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2022.02.013"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.gastha.2024.03.003"},{"key":"e_1_2_9_35_1","first-page":"26","article-title":"Comparison of the Efficacy and Safety of mometasone Furoate to Other Inhaled Steroids for Asthma: A Meta\u2010Analysis","volume":"31","author":"Yang D.","year":"2013","journal-title":"Asian Pacific Journal of Allergy and Immunology"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2010.02543.x"},{"key":"e_1_2_9_37_1","article-title":"Interventions for Hand Eczema","volume":"4","author":"Christoffers W. A.","year":"2019","journal-title":"Cochrane Database of Systematic Reviews"},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.1177\/009127000004001107"},{"key":"e_1_2_9_39_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2014-308815"},{"key":"e_1_2_9_40_1","first-page":"956","article-title":"In Vitro Glucocorticoid Receptor Binding and Transcriptional Activation by Topically Active Glucocorticoids","volume":"48","author":"Smith C. L.","year":"1998","journal-title":"Arzneimittel\u2010Forschung"},{"key":"e_1_2_9_41_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2021.06.023"},{"key":"e_1_2_9_42_1","doi-asserted-by":"publisher","DOI":"10.21037\/tgh-23-120"}],"container-title":["Alimentary Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/apt.18443","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,8]],"date-time":"2025-01-08T04:43:30Z","timestamp":1736311410000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/apt.18443"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12,16]]},"references-count":41,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,2]]}},"alternative-id":["10.1111\/apt.18443"],"URL":"https:\/\/doi.org\/10.1111\/apt.18443","archive":["Portico"],"relation":{},"ISSN":["0269-2813","1365-2036"],"issn-type":[{"value":"0269-2813","type":"print"},{"value":"1365-2036","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,12,16]]},"assertion":[{"value":"2024-11-16","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-12-04","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-12-16","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}