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Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis (EOS-1)

This study has been completed.
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH Identifier:
First received: April 30, 2015
Last updated: February 2, 2017
Last verified: February 2017
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.

Condition Intervention Phase
Eosinophilic Esophagitis
Drug: Budesonide 1mg orodispersible tablet twice daily
Drug: Placebo orodispersible tablet twice daily
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo-controlled, Phase III Trial on the Efficacy and Tolerability of a 6-week Treatment With Budesonide Effervescent Tablets vs. Placebo for Induction of Clinico-pathological Remission in Adult Patients With Active Eosinophilic Esophagitis

Resource links provided by NLM:

Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • Rate of clinico-pathological remission [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Rate of patients with histological remission [ Time Frame: 6 weeks ]
  • Rate of patients with resolutions of symptoms measured by numerical rating score of symptoms [ Time Frame: week 6 ]

Enrollment: 88
Actual Study Start Date: November 11, 2015
Study Completion Date: October 4, 2016
Primary Completion Date: August 4, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Budesonide
Budesonide 1mg orodispersible tablet twice daily
Drug: Budesonide 1mg orodispersible tablet twice daily
Placebo Comparator: Placebo
Placebo orodispersible tablet twice daily
Drug: Placebo orodispersible tablet twice daily


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent,
  • Male or female patients, 18 to 75 years of age,
  • Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
  • Active symptomatic and histological EoE,
  • A documented trial with proton pump inhibitors (PPIs) in order to rule out PPI-responsive esophageal eosinophilia,
  • Negative pregnancy test in females of childbearing potential at baseline visit.

Exclusion Criteria:

  • Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),
  • History of abnormal results in case of an optionally performed pH-monitoring of the distal esophagus,
  • Patients with PPI-responsive esophageal eosinophilia
  • Achalasia, scleroderma esophagus, or systemic sclerosis,
  • Other clinically evident causes than EoE for esophageal eosinophilia,
  • Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection [candida esophagitis]),
  • Any relevant systemic disease (e.g., AIDS, active tuberculosis),
  • If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,
  • Liver cirrhosis or portal hypertension,
  • History of cancer in the last five years,
  • History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit,
  • Upper gastrointestinal bleeding within 8 weeks prior to screening visit,
  • Existing or intended pregnancy or breast-feeding.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02434029

Center for Digestive Diseases Eppendorf
Hamburg, Germany, 20249
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Study Director: Ralph Mueller, PhD Dr. Falk Pharma GmbH
  More Information

Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT02434029     History of Changes
Other Study ID Numbers: BUL-1/EEA
2014-001484-12 ( EudraCT Number )
Study First Received: April 30, 2015
Last Updated: February 2, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on April 25, 2017