The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
308
Twice daily intake of the tablet 30 min after a meal
Dr. Falk Investigational Site
Scottsdale, Arizona, United States
Proportion of patients in histological remission
Histological assessment of biopsies taken at end of treatment visit
Time frame: 6 weeks
Proportion of patients in clinical remission
Assessment of clinical scores assessed with questionnaires at the end of treatment visit
Time frame: 6 weeks
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Dr. Falk Investigational Site
Little Rock, Arkansas, United States
Dr. Falk Investigational Site
La Jolla, California, United States
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San Diego, California, United States
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Dr. Falk Investigational Site
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Boston, Massachusetts, United States
Wyoming
Ann Arbor, Michigan, United States
Dr. Falk Investigational Site
Wyoming, Michigan, United States
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