Budesonide for Eosinophilic Esophagitis (BEE)

This study has been completed.
Sponsor:
Information provided by:
Swiss EE Study Group
ClinicalTrials.gov Identifier:
NCT00271349
First received: December 29, 2005
Last updated: April 20, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Eosinophilic Esophagitis
Drug: Budesonide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Budesonide for Eosinophilic Esophagitis: a Randomized, Placebo-Controlled, Double-Blind Treatment Study

Resource links provided by NLM:


Further study details as provided by Swiss EE Study Group:

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.

Enrollment: 28
Study Start Date: December 2005
Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   14 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271349

Locations
Switzerland
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00271349     History of Changes
Other Study ID Numbers: D5257L00017, D5257L00017
Study First Received: December 29, 2005
Last Updated: April 20, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss EE Study Group:
Eosinophilic Esophagitis
Budesonide

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 20, 2014