Fluticasone Propionate (FP) Treatment for Eosinophilic Esophagitis
The Cincinnati Center for Eosinophilic Disorders at Cincinnati Children's Hospital Medical Center is currently conducting a double blinded, randomized trial of swallowed 1760mcg Fluticasone propionate (FP) versus placebo in the treatment of Eosinophilic Esophagitis. The purpose of this study is to test the effects (both good and bad) of swallowed fluticasone propionate (Flovent), in subjects with eosinophilic esophagitis (EE).
Eligibility
Inclusion Criteria:
- Signed informed consent for study by subject, or parent / guardian if subject is a minor
- Active Eosinophilic Esophagitis, as defined by eosinophil count of ≥24 per high power field (400x) in the biopsies taken from the esophagus
- Allergy evaluation including skin-prick testing with multiple food antigens to ensure elimination diet (removing foods that subject is allergic to) 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 prior to endoscopy OR failure of histological improvement as defined by <1 eosinophil per HPF after 2 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 Criteria:
- History of poor tolerance to 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 a metered-dose inhaler (MDI)
- Pregnant females
- Inhaling any corticosteroid for asthma
- Concurrent or recent (within 3 months) use of systemic or chronic daily inhaled 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
If you are a patient who may be interested in enrolling in this research study or you have further questions, please contact us at 513-636-5540.
Marc E. Rothenberg, MD, PhD
Bridget Buckmeier
bridget.buckmeier@cchmc.org
513-636-5540
