A Study of Flovent in Patients With Eosinophilic Esophagitis

Condition(s) targeted: Eosinophilic Esophagitis

Intervention: Flovent (Drug); Placebo (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: Children's Hospital Medical Center, Cincinnati

Official(s) and/or principal investigator(s):
Marc E. Rothenberg, M.D., Ph.D., Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati

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

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).

Official title: A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis

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

Primary outcome: 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.

Secondary outcome:

To investigate the safety of 1760mcg FP in the treatment of EE using measurement of serial salivary cortisol levels and adverse reaction data.

To investigate the relationship between subject age, height, weight, allergic status and response to FP.

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.

To investigate subject compliance and response to FP.

To investigate the change in subject symptoms and response to FP.

Minimum age: 3 Years. Maximum age: 30 Years. Gender(s): Both.

Criteria:

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.

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

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States; Recruiting

Cincinnati Center for Eosinophilic Disorders

Starting date: January 2007
Ending date: January 2010
Last updated: October 24, 2008