Budesonide for Eosinophilic Esophagitis (BEE)

Budesonide for Eosinophilic Esophagitis: a Randomized, Placebo-controlled, Double-blind Treatment Study

Eosinophilic Esophagitis (EE) is a chronic, T-helper 2 cell (TH2) - type inflammatory disorder of the esophagus with a rapidly increasing prevalence. Studies analyzing the natural course of EE provide strong evidence, that the chronic inflammation leads to irreversible structural changes in the esophagus with a loss of the mucosal elasticity and a fibrosis of the sub-epithelial esophageal layers with a concomitant risk of impairment in function.

Treatment strategies in chronic inflammations have, in general, two main goals: 1) Relief of symptoms and 2) Prevention of long-term damage of the affected organ. Until now, the treatment of EE is still controversial. Standard recommendations for therapy of this chronic eosinophilic inflammation include dilation, systemic or topical corticosteroids and leukotriene antagonists. Several of these reports demonstrate, that topical corticosteroids may be effective for symptom control as well as for down-regulating the local inflammation. Furthermore it has been demonstrated, that treatment with topical corticosteroids is as effective as oral prednisone. However, the majority of therapeutic recommendations are based on clinical observations, case reports or small case series.

The purpose of this study is the evaluation of the efficacy and the safety of a monotherapy with a topical corticosteroid as short-term induction-treatment and as long-term, maintenance-treatment compared with placebo, in the treatment of adult patients with active EE.

Study Overview

• Status: Completed
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Drug: Budesonide

Detailed Description

A randomized, double-blind, placebo-controlled, single center clinical trial to evaluate the efficacy and safety of topically applied Budesonide in the treatment of adult patients with Eosinophilic Esophagitis.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Solothurn
    • Olten, Solothurn, Switzerland, 4600
      • Department of Gastroenterology, Kantonsspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Isolated Eosinophilic Esophagitis
• Adult patients (age > 14 years)
• Active disease (clinically and histologically)
• Informed Consent

Exclusion Criteria:

• Current use of specific treatments for EE
• Secondary causes of esophageal eosinophilia
• Intolerance to Budesonide
• Concomitant therapies for any reason that may affect assessment
• Use of an investigational drug with 30 days of entering the study
• Recent history or suspicion of current drug abuse and alcohol abuse
• Positive serum pregnancy test at the screening visit
• Any unstable serious co-existing medical condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy of Budesonide in inducing a reduction of the esophageal eosinophilic infiltration in adult individuals with active EE after 2 weeks of induction-treatment.
Efficacy of Budesonide in sustaining a reduction of the esophageal eosinophilic infiltration in adult individuals with quiescent EE after 50 weeks of maintenance-treatment.

Secondary Outcome Measures

Outcome Measure
Efficacy of Budesonide in inducing a reduction of the clinical manifestations of active EE after 2 weeks of induction-treatment.
Efficacy of Budesonide in sustaining a reduction of the clinical manifestations of quiescent EE after 50 weeks of maintenance-treatment.
Efficacy of a one year treatment with Budesonide on esophageal remodeling in adult subjects with EE.

Collaborators and Investigators

• Sponsor: Swiss EE Study Group
• Investigators: Study Chair: Christoph Beglinger, MD, Department of Gastroenterology, University Hospital Basel, Switzerland; Study Director: Hans-Uwe Simon, MD, PhD, Department of Pharmacology, University of Bern, Switzerland; Principal Investigator: Alex Straumann, MD, Department of Gastroenterology, Kantonsspital Olten, Switzerland

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: December 29, 2005
• First Submitted That Met QC Criteria: December 29, 2005
• First Posted (Estimate): December 30, 2005

Study Record Updates

• Last Update Posted (Estimate): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Eosinophilic Esophagitis; Budesonide
• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: D5257L00017