Clinical Trials Office

Fluticasone Propionate (FP) Treatment

What is the purpose of this study?

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).

Who can participate?

  • 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

Conditions

  • Eosinophilic Disorders
  • Medications

Who should I contact for more information?

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.

 

 

Date

Ongoing