{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:23:26Z","timestamp":1792787006546,"version":"4.5.0"},"reference-count":31,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2020,3,9]],"date-time":"2020-03-09T00:00:00Z","timestamp":1583712000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Adare Pharmaceuticals, Inc"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2020,4]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>APT\u20101011, a fluticasone propionate orally disintegrating tablet formulation, 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 safety and tolerability of APT\u20101011 administered to patients with EoE and to assess the effect on clinical symptoms of EoE, endoscopic appearance and oesophageal eosinophilia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A randomised, double\u2010blind, placebo\u2010controlled, multicentre, phase 1b\/2a study was conducted at seven medical centres in the US to evaluate the safety and tolerability of APT\u20101011 over 8 weeks in adults and adolescents with EoE. Participants were randomised to placebo (n\u00a0=\u00a08), 1.5\u00a0mg APT\u20101011 BID (n\u00a0=\u00a08) or 3.0\u00a0mg APT\u20101011 QD (n\u00a0=\u00a08). Safety and tolerability were assessed as the primary outcome; histologic and endoscopic measures were assessed as exploratory outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>There were no deaths, serious treatment\u2010emergent adverse events (TEAEs), severe TEAEs or discontinuations from the study related to a TEAE. In one participant randomised to 1.5\u00a0mg APT\u20101011 BID, a reduction in cortisol was observed, but without evidence of adrenal insufficiency. Compared with placebo, treatment with APT\u20101011 resulted in greater reductions in oesophageal eosinophil counts, EoE Endoscopic Reference Score, patient global assessment and symptom\u2010based EoE activity index from baseline to end of treatment (Week 8).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>APT\u20101011 was safe and well tolerated in adolescents and adults with EoE. Exploratory efficacy outcomes demonstrated improvement in histologic and endoscopic findings as well evidence of symptom improvement. The results of this study support the continued development of APT\u20101011 for the treatment of EoE (NCT\u201001386112).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.15670","type":"journal-article","created":{"date-parts":[[2020,3,9]],"date-time":"2020-03-09T05:11:27Z","timestamp":1583730687000},"page":"750-759","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":42,"title":["Randomised clinical trial: the safety and tolerability of fluticasone propionate orally disintegrating tablets versus placebo for eosinophilic oesophagitis"],"prefix":"10.1111","volume":"51","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7688-9377","authenticated-orcid":false,"given":"Ikuo","family":"Hirano","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Hepatology Feinberg School of Medicine Northwestern University Chicago IL 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