Phase 2
Completed N=32
Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
Source: ClinicalTrials.gov NCT00638456 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Number of Participants With Improvement of Espohageal Eosinophilia — 13; 0 Participants
Summary
This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Improvement of Espohageal Eosinophilia |
13; 0 | — |
| SECONDARY Upper Gastrointestinal Endoscopy Score |
4.6; 7.8; 1.5; 5.4 | — |
| SECONDARY Symptom Score |
3.5; 2.7; 1.2; 1.8 | — |
Eligibility Criteria
Inclusion Criteria
- Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal biopsy
- Ages 1 yrs and older
- Ability to continue the same diet that the patient was on at the time of EGD with biopsy
Exclusion Criteria
- Adverse reaction or allergy to budesonide
- Pregnancy
- Chronic diseases requiring immunomodulatory therapy
- Use of swallowed topical corticosteroids for EE within the past 3 months
- Use of systemic steroids 2 months prior to study entry
- Upper gastrointestinal bleed within 4 months of study entry
- Chronic use of medications that predispose to upper gastrointestinal bleeding including non-steroidal anti-inflammatory medications or anticoagulants
- Evidence of adrenal suppression prior to study entry
- Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis
- Recent changes in asthma or allergic rhinitis therapy for 3 months
Data sourced from ClinicalTrials.gov (NCT00638456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.