BEE: Budesonide for Eosinophilic Esophagitis

Sponsor

Swiss EE Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00271349

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Eosinophilic Esophagitis	Drug: Budesonide	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

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

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, Kantonsspital	Olten	Solothurn	Switzerland	4600

Sponsors and Collaborators

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