Status:
COMPLETED
Topical Steroid Treatment for Eosinophilic Esophagitis
Lead Sponsor:
Mayo Clinic
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 becom...
Detailed Description
This was a double-blind randomized placebo controlled trial to evaluate the effect of aerosolized fluticasone therapy on symptomatic dysphagia and histologic eosinophilia in adults newly diagnosed wit...
Eligibility Criteria
Inclusion
- \> 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00275561
Start Date
November 1 2005
End Date
April 1 2010
Last Update
May 8 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905