Official Title: “A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate 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).

Study Type: Interventional

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

Study Primary Completion Date: January 2010

Intervention(s) in this Clinical Trial

• Drug: Flovent
  • 1760 mcg daily
• Other: Placebo
  • 1760 mcg daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Drug
• Placebo Comparator: 2

Primary Measures

• To investigate the ability of 1760mcg fluticasone propionate (FP) swallowed from a metered-dose inhaler (MDI) to induce remission of eosinophilic esophagitis (EE) (highest count of eosinophils per HPF for all esophageal biopsies to < 1 cell per HPF.
  • Time Frame: three years (anticipated)
    Safety Issue?: No

Secondary Measures

• To investigate the safety of 1760mcg FP in the treatment of EE using measurement of serial salivary cortisol levels and adverse reaction data.
  • Time Frame: three years (anticipated)
    Safety Issue?: Yes
• To investigate the relationship between subject age, height, weight, allergic status and response to FP.
  • Time Frame: three years (anticipated)
    Safety Issue?: No
• To investigate the relationship between gene expression, blood levels (CBC, serum IL-5, eotaxin-3 and IgE) eosinophil phenotype, (via flow cytometry and functional responses) and response to FP.
  • Time Frame: three years (anticipated)
    Safety Issue?: No
• To investigate subject compliance and response to FP.
  • Time Frame: three years (anticipated)
    Safety Issue?: No
• To investigate the change in subject symptoms and response to FP.
  • Time Frame: three years (anticipated)
    Safety Issue?: No

Inclusion Criteria:

• 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 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 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.

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  

Overall Contact: Bridget K Buckmeier, B.A. 513-636-5540 bridget.buckmeier@cchmc.org

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00426283

Study ID Number: 06-10-07

ClinicalTrials.gov Identifier: NCT00426283

Health Authority: United States: Food and Drug Administration

Cincinnati Center for Eosinophilic Disorders