Status:
COMPLETED
A Study of Flovent in Patients With Eosinophilic Esophagitis
Lead Sponsor:
Marc Rothenberg, MD
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
3-30 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the effects (both good and bad) of high dose swallowed fluticasone propionate (Flovent) in subjects with eosinophilic esophagitis (EoE).
Eligibility Criteria
Inclusion
- Signed informed consent for study by subject, or parent/guardian if subject is a minor. Assent will be obtained from all minors 11 years of age and older.
- Histological findings on esophageal biopsy to include peak eosinophil density ≥ 24 per high power field (400x) in the proximal or distal esophagus validated by a pathologist at CCHMC.
- Allergy evaluation including skin-prick testing with multiple food antigens to ensure elimination diet is not indicated.
- Have undergone a minimum 3 months of elimination diet as indicated by skin-prick testing without detectable resolution by repeat endoscopy with biopsies demonstrating persistent EE OR subject/parental refusal to follow elimination diet. If the subject/parent refuses the elimination diet, they are eligible for this study.
- Treatment with a proton-pump inhibitor for at least two months (rounded to nearest month) prior to endoscopy OR failure of histological improvement as defined by \< 1 eosinophil per HPF after 2 month (rounded to nearest month) trial of proton pump inhibitor documented by prior endoscopy. The PPI must be used prior to endoscopy to rule out the possibility of GERD.
Exclusion
- History of poor tolerance to Fluticasone Propionate (FP), as defined as multiple episodes of oral candidiasis, hypothalamic-pituitary-adrenal axis suppression as evidenced by signs of Cushing syndrome, headaches, or increased respiratory infections during exposure to Flovent
- Unable to cooperate with use of MDI
- Pregnant females
- Concurrent or recent (within 3 months) use of systemic corticosteroids.
- Unable to swallow medicines (i.e., fed only by gastrostomy tube).
- Comorbid eosinophilic disorders.
- Previously treated with swallowed glucocorticoid for EE within 3 months of the screening visit. Nasal glucocorticoids taken for EE are permitted.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00426283
Start Date
January 1 2007
End Date
March 1 2012
Last Update
October 19 2020
Active Locations (4)
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1
The Children's Hospital of Denver
Aurora, Colorado, United States, 80045
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
4
University of Utah
Salt Lake City, Utah, United States, 84132