title: A randomised, double-blind trial comparing budesonide formulations and dosages for short-term treatment of eosinophilic oesophagitis.
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).
  
  
  METHODS
  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/mm(2 )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.
  NCT02280616; EudraCT number, 2009-016692-29.
authors: Centre for Digestive Diseases Eppendorf, Hamburg, Germany.
authors: Stephan
authors: S
authors: Miehlke
authors: Department of Gastroenterology & Hepatology, University Hospital, Basel, Switzerland.
authors: Petr
authors: P
authors: Hruz
authors: Institute for Pathology, Klinikum Bayreuth, Bayreuth, Germany.
authors: Michael
authors: M
authors: Vieth
authors: Institute for Pathology, Kantonsspital, Luzern, Switzerland.
authors: Christian
authors: C
authors: Bussmann
authors: Department of Gastroenterology & Hepatology, University Hospital, Magdeburg, Germany.
authors: Ulrike
authors: U
authors: von Arnim
authors: Department of Gastroenterology, Technical University Hospital, Munich, Germany.
authors: Monther
authors: M
authors: Bajbouj
authors: Department of Gastroenterology, Technical University Hospital, Munich, Germany.
authors: Christoph
authors: C
authors: Schlag
authors: Medical Department I, Klinikum Siloah, Hannover, Germany.
authors: Ahmed
authors: A
authors: Madisch
authors: Medical Department, Israelitisches Krankenhaus, Hamburg, Germany.
authors: Christiane
authors: C
authors: Fibbe
authors: Department of Internal Medicine, Division of Gastroenterology and Rheumatology, University of Leipzig, Leipzig, Germany.
authors: Henning
authors: H
authors: Wittenburg
authors: Medical Department, Klinikum Garmisch-Partenkirchen, Garmisch-Partenkirchen, Germany.
authors: Hans Dieter
authors: HD
authors: Allescher
authors: Medical Department, Klinikum Braunschweig, Braunschweig, Germany.
authors: Max
authors: M
authors: Reinshagen
authors: Gastroenterologist in Private Practice, Berlin, Germany.
authors: Stefan
authors: S
authors: Schubert
authors: Department of Gastroenterology, University Hospital, Leuven, Belgium.
authors: Jan
authors: J
authors: Tack
authors: Department of Gastroenterology, Deutsche Klinik für Diagnostik, Wiesbaden, Germany.
authors: Michaela
authors: M
authors: Müller
authors: Department of Internal Medicine, Krankenhaus Martha-Maria Halle-Dölau, Halle (Saale), Germany.
authors: Patrick
authors: P
authors: Krummenerl
authors: Department of Gastroenterology, AZ Sint-Lucas Brugge, Brugge, Belgium.
authors: Joris
authors: J
authors: Arts
authors: Dr. Falk Pharma GmbH, Freiburg, Germany.
authors: Ralph
authors: R
authors: Mueller
authors: Dr. Falk Pharma GmbH, Freiburg, Germany.
authors: Karin
authors: K
authors: Dilger
authors: Dr. Falk Pharma GmbH, Freiburg, Germany.
authors: Roland
authors: R
authors: Greinwald
authors: Swiss EoE Research Network, Olten, Switzerland.
authors: Alex
authors: A
authors: Straumann
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D057765:Eosinophilic Esophagitis / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D013535:Suspensions; D013607:Tablets; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D013535:Suspensions; D013607:Tablets; D019819:Budesonide
keywords: DYSPHAGIA; OESOPHAGITIS