Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis

Summary

The purpose of this study is to prove the superiority of a 6-weeks treatment with budesonide effervescent tablets versus placebo for the induction of clinico-pathological remission in patients with acute eosinophilic esophagitis.

Timeline

Start

2015-11-11

Primary completion

2016-08-04

Completion

2016-10-04

Outcome

Met primary endpoint

paper At 6 weeks, 58% of patients given BOT were in complete remission compared with no patients given placebo (P < .0001). PMID 30922997 ↗

paper In a randomized trial of adults with active EoE, we found that budesonide oral tablets were significantly more effective than placebo in inducing clinical and histologic remission. PMID 30922997 ↗

Publications

• Straumann A, Lucendo AJ, Miehlke S, Vieth M, Schlag C, Biedermann L, Vaquero CS, Ciriza de Los Rios C, Schmoecker C, Madisch A, Hruz P, Hayat J, von Arnim U, Bredenoord AJ, Schubert S, Mueller R, Greinwald R, Schoepfer A, Attwood S; International EOS-2 Study Group. Budesonide Orodispersible Tablets Maintain Remission in a Randomized, Placebo-Controlled Trial of Patients With Eosinophilic Esophagitis. Gastroenterology. 2020 Nov;159(5):1672-1685.e5. doi: 10.1053/j.gastro.2020.07.039. Epub 2020 Jul 25.
• Lucendo AJ, Miehlke S, Schlag C, Vieth M, von Arnim U, Molina-Infante J, Hartmann D, Bredenoord AJ, Ciriza de Los Rios C, Schubert S, Bruckner S, Madisch A, Hayat J, Tack J, Attwood S, Mueller R, Greinwald R, Schoepfer A, Straumann A; International EOS-1 Study Group. Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial. Gastroenterology. 2019 Jul;157(1):74-86.e15. doi: 10.1053/j.gastro.2019.03.025. Epub 2019 Mar 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	1 mg	Oral

Indications