Budesonide for Eosinophilic Esophagitis

NCT ID: NCT00271349

Last Updated: 2015-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2008-12-31

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.

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.

Conditions

Eosinophilic Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Budesonide

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss EE Study Group

OTHER

Sponsor Role: lead

Principal Investigators

Christoph Beglinger, MD

Role: STUDY_CHAIR

Department of Gastroenterology, University Hospital Basel, Switzerland

Hans-Uwe Simon, MD, PhD

Role: STUDY_DIRECTOR

Department of Pharmacology, University of Bern, Switzerland

Alex Straumann, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Kantonsspital Olten, Switzerland

Locations

Department of Gastroenterology, Kantonsspital

Olten, Canton of Solothurn, Switzerland

Countries

Switzerland

Other Identifiers

D5257L00017

Identifier Type: -

Identifier Source: secondary_id

D5257L00017

Identifier Type: -

Identifier Source: org_study_id