Article Text

Original article
A randomised, double-blind trial comparing budesonide formulations and dosages for short-term treatment of eosinophilic oesophagitis
  1. Stephan Miehlke1,
  2. Petr Hruz2,
  3. Michael Vieth3,
  4. Christian Bussmann4,
  5. Ulrike von Arnim5,
  6. Monther Bajbouj6,
  7. Christoph Schlag6,
  8. Ahmed Madisch7,
  9. Christiane Fibbe8,
  10. Henning Wittenburg9,
  11. Hans Dieter Allescher10,
  12. Max Reinshagen11,
  13. Stefan Schubert12,
  14. Jan Tack13,
  15. Michaela Müller14,
  16. Patrick Krummenerl15,
  17. Joris Arts16,
  18. Ralph Mueller17,
  19. Karin Dilger17,
  20. Roland Greinwald17,
  21. Alex Straumann18
  1. 1Centre for Digestive Diseases Eppendorf, Hamburg, Germany
  2. 2Department of Gastroenterology & Hepatology, University Hospital, Basel, Switzerland
  3. 3Institute for Pathology, Klinikum Bayreuth, Bayreuth, Germany
  4. 4Institute for Pathology, Kantonsspital, Luzern, Switzerland
  5. 5Department of Gastroenterology & Hepatology, University Hospital, Magdeburg, Germany
  6. 6Department of Gastroenterology, Technical University Hospital, Munich, Germany
  7. 7Medical Department I, Klinikum Siloah, Hannover, Germany
  8. 8Medical Department, Israelitisches Krankenhaus, Hamburg, Germany
  9. 9Department of Internal Medicine, Division of Gastroenterology and Rheumatology, University of Leipzig, Leipzig, Germany
  10. 10Medical Department, Klinikum Garmisch-Partenkirchen, Garmisch-Partenkirchen, Germany
  11. 11Medical Department, Klinikum Braunschweig, Braunschweig, Germany
  12. 12Gastroenterologist in Private Practice, Berlin, Germany
  13. 13Department of Gastroenterology, University Hospital, Leuven, Belgium
  14. 14Department of Gastroenterology, Deutsche Klinik für Diagnostik, Wiesbaden, Germany
  15. 15Department of Internal Medicine, Krankenhaus Martha-Maria Halle-Dölau, Halle (Saale), Germany
  16. 16Department of Gastroenterology, AZ Sint-Lucas Brugge, Brugge, Belgium
  17. 17Dr. Falk Pharma GmbH, Freiburg, Germany
  18. 18Swiss EoE Research Network, Olten, Switzerland
  1. Correspondence to Professor Stephan Miehlke, Centre for Digestive Diseases Eppendorf, Eppendorfer Landstraße 42, Hamburg 20249, Germany; prof.miehlke{at}mdz-hamburg.de

Abstract

Objective To investigate the efficacy and safety of two different budesonide formulations (effervescent tablet for orodispersible use (BET) and viscous suspension (BVS)) with different daily dosages for short-term treatment of eosinophilic oesophagitis (EoE).

Design Adults with active EoE (n=76) randomly received 14 days’ treatment with either BET 2×1 mg/day (BET1, n=19) or BET 2×2 mg/day (BET2, n=19), or BVS 2×5 mL (0.4 mg/mL)/day (BVS, n=19) or placebo (n=19) in a double-blind, double-dummy fashion, with a 2-week follow-up. Primary end point was histological remission (mean of <16 eosinophils/mm2 hpf). Secondary end points included endoscopy score, dysphagia score, drug safety and patient's preference for drug formulation.

Results Histological remission occurred in 100%, 94.7% and 94.7% of budesonide (BET1, BET2, BVS, respectively) and in 0% of placebo recipients (p<0.0001). The improvement in total endoscopic intensity score was significantly higher in the three budesonide groups compared with placebo. Dysphagia improved in all groups at the end of treatment; however, improvement of dysphagia persisted only in those treated with BET1 (p=0.0196 vs placebo). There were no serious adverse events. Local fungal infection (stained fungi) occurred in two patients of each budesonide group (10.5%). The effervescent tablet was preferred by 80% of patients.

Conclusions BET or BVS was highly effective and safe for short-term treatment of EoE. The 1 mg (twice daily) dosage was equally effective as the 2 mg twice daily dosage. The majority of patients preferred the effervescent tablet formulation.

ClinicalTrials.gov number NCT02280616; EudraCT number, 2009-016692-29.

  • OESOPHAGITIS
  • DYSPHAGIA

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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