Abstract
APT-1011, a fluticasone propionate orally disintegrating tablet formulation, is under investigation for the treatment of eosinophilic oesophagitis (EoE). To evaluate the safety and tolerability of APT-1011 administered to patients with EoE and to assess the effect on clinical symptoms of EoE, endoscopic appearance and oesophageal eosinophilia. A randomised, double-blind, placebo-controlled, multicentre, phase 1b/2a study was conducted at seven medical centres in the US to evaluate the safety and tolerability of APT-1011 over 8 weeks in adults and adolescents with EoE. Participants were randomised to placebo (n = 8), 1.5 mg APT-1011 BID (n = 8) or 3.0 mg APT-1011 QD (n = 8). Safety and tolerability were assessed as the primary outcome; histologic and endoscopic measures were assessed as exploratory outcomes. There were no deaths, serious treatment-emergent adverse events (TEAEs), severe TEAEs or discontinuations from the study related to a TEAE. In one participant randomised to 1.5 mg APT-1011 BID, a reduction in cortisol was observed, but without evidence of adrenal insufficiency. Compared with placebo, treatment with APT-1011 resulted in greater reductions in oesophageal eosinophil counts, EoE Endoscopic Reference Score, patie...Continue Reading
References
Jan 5, 2001·Clinical Pharmacokinetics·C BrindleyA Bye
Jan 5, 2001·Clinical Pharmacokinetics·A E MackieP T Daley-Yates
Jan 16, 2004·Gastroenterology·Alex StraumannHans-Uwe Simon
Jun 4, 2005·Gastrointestinal Endoscopy·Tusar K DesaiGlenn T Furuta
May 19, 2007·Diseases of the Esophagus : Official Journal of the International Society for Diseases of the Esophagus·A B M GrudellY Romero
Oct 9, 2007·Gastroenterology·Glenn T FurutaUNKNOWN First International Gastrointestinal Eosinophil Research Symposium (FIGERS) Subcommittees
Feb 2, 2008·Health and Quality of Life Outcomes·Károly R KulichIngela K Wiklund
Oct 27, 2009·Dysphagia·Judith McElhineyYvonne Romero
Nov 9, 2010·Journal of Pediatric Gastroenterology and Nutrition·Jonathan M SpergelPeter A Bonis
Apr 12, 2011·The Journal of Allergy and Clinical Immunology·Chris A LiacourasSeema S Aceves
Apr 6, 2012·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Jeffrey A AlexanderNicholas J Talley
May 9, 2012·Gastroenterology·Evan S DellonNicholas J Shaheen
May 24, 2012·Gut·Ikuo HiranoSami R Achem
Sep 6, 2012·Diseases of the Esophagus : Official Journal of the International Society for Diseases of the Esophagus·R T KavittM F Vaezi
Apr 10, 2013·The American Journal of Gastroenterology·Evan S DellonUNKNOWN American College of Gastroenterology
Aug 21, 2013·Gastroenterology·Alain M SchoepferAlex Straumann
Apr 29, 2014·Gastroenterology·Bridget K ButzMarc E Rothenberg
Aug 28, 2014·Gastroenterology·Alain M SchoepferUNKNOWN International Eosinophilic Esophagitis Activity Index Study Group
Oct 1, 2014·The American Journal of Gastroenterology·Elizabeth T JensenEvan S Dellon
Feb 3, 2016·Alimentary Pharmacology & Therapeutics·S LipkaJ E Richter
Mar 5, 2016·Alimentary Pharmacology & Therapeutics·H PhilpottP R Gibson
Mar 28, 2017·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Ikuo HiranoEvan S Dellon
May 17, 2017·United European Gastroenterology Journal·Alfredo J LucendoStephen E Attwood
Aug 5, 2017·Gastroenterology·Evan S Dellon, Ikuo Hirano
Apr 4, 2018·Digestive Diseases and Sciences·Ryan WangTiffany Taft
Apr 28, 2018·The American Journal of Gastroenterology·Marijn J WarnersAlbert J Bredenoord
Jul 17, 2018·Gastroenterology·Evan S DellonAlbert J Bredenoord
Aug 7, 2018·Gastroenterology·Ikuo Hirano
Nov 1, 2018·Diseases of the Esophagus : Official Journal of the International Society for Diseases of the Esophagus·L KiaI Hirano
Mar 30, 2019·Gastroenterology·Alfredo J LucendoUNKNOWN International EOS-1 Study Group
Citations
Apr 28, 2020·Alimentary Pharmacology & Therapeutics·Ikuo HiranoGary W Falk
Apr 28, 2020·Alimentary Pharmacology & Therapeutics·Joel E Richter
Jun 23, 2020·Expert Review of Gastroenterology & Hepatology·Aditi ReddyArvind R Murali
Aug 8, 2020·Annals of the New York Academy of Sciences·Nielsen Q Fernandez-BeckerJennifer L Horsley-Silva
Oct 4, 2020·Current Opinion in Gastroenterology·Erin Phillips Syverson, Elizabeth J Hait
Dec 12, 2020·Diseases of the Esophagus : Official Journal of the International Society for Diseases of the Esophagus·Corey J KetchemEvan S Dellon
Feb 4, 2021·Digestive Diseases and Sciences·Amanda H LimNam Q Nguyen
Oct 15, 2020·Digestive Diseases and Sciences·Evan S Dellon
Jun 23, 2021·Zeitschrift für Gastroenterologie·Stephan MiehlkeAhmed Madisch
Oct 25, 2021·The Journal of Allergy and Clinical Immunology. in Practice·Noam ZevitEvan S Dellon