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FLUTicasone in Eosinophilic Esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects With Eosinophilic Esophagitis

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Trial Profile

FLUTicasone in Eosinophilic Esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects With Eosinophilic Esophagitis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 Apr 2023

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At a glance

  • Drugs Fluticasone propionate (Primary)
  • Indications Eosinophilic oesophagitis
  • Focus Therapeutic Use
  • Acronyms FLUTE; FLUTE 1
  • Sponsors Adare Pharmaceuticals

Most Recent Events

  • 27 Oct 2021 Results of post-hoc analysis examining the threshold for a clinically meaningful change in dysphagia frequency and the time to achieve this change, presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2021
  • 27 Oct 2021 Results assessing dysphagia symptoms as measured by the patient reported outcomes for the symptoms of eosinophilic esophagitis (PROSE) diary by examining the safety, efficacy and pharmacokinetics of APT-1011 for eosinophilic esophagitis, presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2021.
  • 23 May 2021 Results (n=99)post-hoc analysis assessing the effect of APT-1011 treatment response rates overall and in patients with strictures and/or grade 2 rings presented at the Digestive Disease Week 2021

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