Phase 2
N=42
Topical Steroid Treatment for Eosinophilic Esophagitis
Eosinophilic Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT00275561 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Number of Participants With Complete Response to Dysphagia — 9; 6 participants — p=0.74
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluticasone (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Response to Dysphagia |
9; 6 | 0.74 |
| SECONDARY Number of Participants With Partial or Complete Response to Dysphagia |
12; 7 | 0.49 |
| SECONDARY Number of Participants With Complete Histologic Response |
13; 0 | <0.001 sig |
Summary
This was a randomized controlled trial of swallowed fluticasone vs. placebo for eosinophilic esophagitis. Eosinophilic esophagitis is an inflammatory condition in which the wall of the esophagus becomes filled with large numbers of eosinophils, a type of white blood cell. Patients who have this condition have difficulty in swallowing (dysphagia) solid food.
Prior to treatment the patients had biopsies of their esophagus and took questionnaires regarding their symptoms. Treatment was given for 6 weeks, after which biopsies were taken from the esophagus to measure any changes in the tissue from before treatment. The primary endpoint was improvement in dysphagia as measured by the validated Mayo Dysphagia Questionaire. Secondary outcomes included partial symptom response, and histologic (tissue) response to treatment.
Eligibility Criteria
Inclusion Criteria
- > 20 eosinophils / hpf on biopsies from mid esophagus (hpf = high-powered field)
- Abnormal dysphagia questionnaire (question 1a "yes", question 1c > "moderate" and question 2 > "less than once a week") on Mayo Dysphagia Questionnaire.
Exclusion Criteria
- Clinical evidence of infectious process potentially contributing to dysphagia (e.g., candidiasis, cytomegalovirus, herpes)
- Systemic or topical steroid therapy for any reason over the past 3 months
- Previous steroid treatment for Eosinophilic Esophagitis
- Intolerance to steroid therapy in the past
- Other cause of dysphagia identified at endoscopy (e.g., reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
- Dilatation of esophagus at time of index endoscopy
Data sourced from ClinicalTrials.gov (NCT00275561). 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.