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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

December 29, 2005
April 20, 2009
December 2005
July 2008   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT00271349 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Budesonide for Eosinophilic Esophagitis
Budesonide for Eosinophilic Esophagitis: a Randomized, Placebo-Controlled, Double-Blind Treatment Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Eosinophilic Esophagitis
Drug: Budesonide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
14 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00271349
D5257L00017, D5257L00017
Not Provided
Not Provided
Swiss EE Study Group
Not Provided
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
Swiss EE Study Group
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP