Budesonide for Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

— BEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271349
• Other study ID #: D5257L00017
• Secondary ID: D5257L00017
• Status: Completed
• Phase: Phase 2
• First received: December 29, 2005
• Last updated: May 21, 2015
• Start date: December 2005
• Est. completion date: December 2008

Study information

• Verified date: April 2009
• Source: Swiss EE Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• Budesonide

Locations

Country	Name	City	State
Switzerland	Department of Gastroenterology, Kantonsspital	Olten	Solothurn

Sponsors (1)

Lead Sponsor	Collaborator
Swiss EE Study Group

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Budesonide in inducing a reduction of the esophageal eosinophilic infiltration in adult individuals with active EE after 2 weeks of induction-treatment.
Primary	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	Efficacy of Budesonide in inducing a reduction of the clinical manifestations of active EE after 2 weeks of induction-treatment.
Secondary	Efficacy of Budesonide in sustaining a reduction of the clinical manifestations of quiescent EE after 50 weeks of maintenance-treatment.
Secondary	Efficacy of a one year treatment with Budesonide on esophageal remodeling in adult subjects with EE.