Budesonide for Eosinophilic Esophagitis: a Randomized, Placebo-Controlled, Double-Blind Treatment Study
Information source: Swiss EE Study Group
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Eosinophilic Esophagitis
Intervention: Budesonide (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Swiss EE Study Group Official(s) and/or principal investigator(s):
Christoph Beglinger, MD, Study Chair, Affiliation: Department of Gastroenterology, University Hospital Basel, Switzerland
Hans-Uwe Simon, MD, PhD, Study Director, Affiliation: Department of Pharmacology, University of Bern, Switzerland
Alex Straumann, MD, Principal Investigator, Affiliation: Department of Gastroenterology, Kantonsspital Olten, Switzerland
Overall contact:
Alex Straumann, MD, Phone: +41 62 212 55 77, Email: alex.straumann@hin.ch
Summary
Eosinophilic Esophagitis (EE) is a chronic, 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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: 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.
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
Minimum age: 14 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
- Concomitent 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
Locations and Contacts
Alex Straumann, MD, Phone: +41 62 212 55 77, Email: alex.straumann@hin.ch
Department of Gastroenterology, Kantonsspital, Olten, Solothurn 4600, Switzerland; Recruiting
Alex Straumann, MD, Phone: +41 62 212 55 77, Email: alex.straumann@hin.ch
Alex Straumann, MD, Principal Investigator
Additional Information
Starting date: December 2005
Last updated: December 29, 2005
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