Budesonide for Eosinophilic Esophagitis

NCT00271349 | Completed Phase 2

• 1 other identifier: D5257L00017
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic Esophagitis; Budesonide

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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.

Interventions

Budesonide DRUG

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss EE Study Group: lead

Study Sites (1)

Department of Gastroenterology, Kantonsspital

Olten, Canton of Solothurn, 4600, Switzerland

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Christoph Beglinger, MD

  Department of Gastroenterology, University Hospital Basel, Switzerland

  STUDY CHAIR

• Hans-Uwe Simon, MD, PhD

  Department of Pharmacology, University of Bern, Switzerland

  STUDY DIRECTOR

• Alex Straumann, MD

  Department of Gastroenterology, Kantonsspital Olten, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2005
• First Posted: December 30, 2005
• Study Start: December 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 22, 2015

Record last verified: 2009-04

Locations

CH (1)