1. Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial
- Author
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Alfredo J. Lucendo, Stephan Miehlke, Christoph Schlag, Michael Vieth, Ulrike von Arnim, Javier Molina-Infante, Dirk Hartmann, Albert Jan Bredenoord, Constanza Ciriza de los Rios, Stefan Schubert, Stefan Brückner, Ahmed Madisch, Jamal Hayat, Jan Tack, Stephen Attwood, Ralph Mueller, Roland Greinwald, Alain Schoepfer, Alex Straumann, Tim Vanuytsel, Hubert Louis, Carmen Musala, Dorothea Frederking, Monther Bajbouj, Simon Nennstiel, Renate Schmelz, Schmelz Heimerl, Anna-Magdalena Stephan, Christiane Fibbe, Niels Liedtke (née Laschinsky), Jutta Keller, Ulrich Rosien, Sebastian Haag, Arne Schneider, Christoph Schmöcker, Hendrik Buchholz, Frank Lammert, Markus Casper, Matthias Reichert, Dirk Sommer, Hubert Mönnikes, Miriam Stengel, Marco Schmidtmann, Michaela Müller, Alexander Eckardt, Till Wehrmann, Peter Armerding, Wolf Peter Hofmann, Thomas Liceni, Arne Kandulski, Jochen Weigt, Norbert Börner, Anne Lutz-Vorderbrügge, Jörg Albert, Stefan Zeuzem, Irina Blumenstein, Kathrin Sprinzl, Johannes Hausmann, Arjan Bredenoord, Marijn Warners, Alfredo Lucendo Villarin, Ángel Arias Arias, Maria Ángeles Tejero Bustos, María Jesús Carrillo Ramos, José María Olalla Gallardo, Rocío Juárez Tosina, José Zamorano, Cecilio Santander Vaquero, Sergio Casabona Francés, Teresa Pérez, Teresa Rodriguez, Constanza Ciriza de los Ríos, Fernando Canga Rodríguez-Valcárcel, Isabel Castel de Lucas, Antonia Perelló Juan, Merce Barenys, Carlos Pons, Isabel Perez Martinez, M. Eugenia Lauret, Andrés Castaño García, Esmeralda Rubio, Petr Hruz, Simon Brunner, Andrew Poullis, Gastroenterology and Hepatology, AGEM - Digestive immunity, and AGEM - Endocrinology, metabolism and nutrition
- Subjects
0301 basic medicine ,Budesonide ,Adult ,Male ,medicine.medical_specialty ,Antifungal Agents ,phase 3 trial ,Placebo-controlled study ,Administration, Oral ,Placebo ,Gastroenterology ,immune response ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Double-Blind Method ,law ,Candidiasis, Oral ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,Eosinophilic esophagitis ,Glucocorticoids ,esophagus ,Hepatology ,business.industry ,Eosinophilic Esophagitis ,Middle Aged ,medicine.disease ,ddc ,030104 developmental biology ,Treatment Outcome ,Tolerability ,patient-reported outcomes ,030211 gastroenterology & hepatology ,Female ,Esophagoscopy ,medicine.symptom ,business ,Odynophagia ,medicine.drug ,Tablets - Abstract
BACKGROUND & AIMS: Swallowed topical-acting corticosteroids are recommended as first-line therapy for eosinophilic esophagitis (EoE). Asthma medications not optimized for esophageal delivery are sometimes effective, although given off-label. We performed a randomized, placebo-controlled trial to assess the effectiveness and tolerability of a budesonide orodispersible tablet (BOT), which allows the drug to be delivered to the esophagus in adults with active EoE. METHODS: We performed a double-blind, parallel study of 88 adults with active EoE in Europe. Patients were randomly assigned to groups that received BOT (1 mg twice daily; n = 59) or placebo (n = 29) for 6 weeks. The primary end point was complete remission, based on clinical and histologic factors, including dysphagia and odynophagia severity ≤2 on a scale of 0-10 on each of the 7 days before the end of the double-blind phase and a peak eosinophil count
- Published
- 2019