Oesophagus
ORIGINAL ARTICLE
Stephan Miehlke,1 Petr Hruz,2 Michael Vieth,3 Christian Bussmann,4 Ulrike von Arnim,5 Monther Bajbouj,6 Christoph Schlag,6 Ahmed Madisch,7 Christiane Fibbe,8 Henning Wittenburg,9 Hans Dieter Allescher,10 Max Reinshagen,11 Stefan Schubert,12 Jan Tack,13 Michaela Müller,14 Patrick Krummenerl,15 Joris Arts,16 Ralph Mueller,17 Karin Dilger,17 Roland Greinwald,17 Alex Straumann18 ▸ Additional material is published online only. To view please visit the journal online (http://dx.doi.org/10.1136/ gutjnl-2014-308815). For numbered affiliations see end of article. Correspondence to Professor Stephan Miehlke, Centre for Digestive Diseases Eppendorf, Eppendorfer Landstraße 42, Hamburg 20249, Germany;
[email protected] SM and PH contributed equally. Received 12 November 2014 Revised 14 January 2015 Accepted 31 January 2015 Published Online First 19 March 2015
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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