Eosinophilic Esophagitis Clinical Trial
Official title:
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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