Official Title: “Effect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled Trial”

The purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the treatment of eosinophilic esophagitis (EE).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2012

Intervention(s) in this Clinical Trial

• Drug: Fluticasone Propionate
  • Flovent vs. placebo daily for 3 months

Primary Measures

• Patients with EE treated with Flovent will demonstrate marked improvement in clinical symptoms, endoscopic findings, and histological abnormalities vs. those treated with placebo.
  • Time Frame: 5 years
    Safety Issue?: No

Secondary Measures

• Patients demonstrating resolution of Flovent will have detectable changes in the expression of genes associated with eosinophilic infiltration by the esophageal mucosa.
  • Time Frame: 5 years
    Safety Issue?: No

Inclusion Criteria:

• Signed informed consent for study by parent or guardian. Assent will be obtained from all minors 11 years of age and older.
• Age older than or equal to 3 years and younger than or equal to 30 years
• Endoscopic findings consistent with EE (edema, furrowing, exudates, rings)
• Histological findings to include proliferation of basal layer and peak eosinophil density ≥24 per high power field (400x). This degree of tissue eosinophilia has been shown to correlate well with poor-responsiveness to acid suppression therapy, suggesting it is a primary eosinophilic disease and not secondary to GERD[11].
• Allergy evaluation including skin-prick testing with multiple food antigens to insure elimination diet is not indicated.
• If allergic to specific foods, option to be on a minimum 3 months of elimination diet without detectable resolution by repeat endoscopy with biopsies demonstrating no improvement to disease.
• Patients enrolled at CCHMC will be under the direct care of Dr. Putnam or any of the other staff gastroenterologists at this institution who will supervise endoscopic procedures. Patients may also be enrolled at institutions other than CCHMC, but the diagnosis of EE must be validated by an expert pathologist in EE at CCHMC (Margaret
• Collins, MD).
• 20 additional patients without EE will be enrolled as unaffected controls for purposes of comparison with patients with EE. Enrollment pool will comprise patients undergoing routine upper endoscopy and having no identifiable pathology.

Exclusion Criteria:

• Patients with history of poor tolerance to FP, patients unable to cooperate with use of MDI, pregnant females, patients inhaling any corticosteroid for asthma, and patients with concurrent or recent (within 3 months) use of systemic steroids.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 30 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Overall Clinical Trial Officials and Contacts

Marc E. Rothenberg, M.D., Ph.D. Principal Investigator Children's Hospital Medical Center, Cincinnati  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00266578

Study ID Number: 02-9-9

ClinicalTrials.gov Identifier: NCT00266578

Health Authority: United States: Institutional Review Board