A Study of Flovent in Patients With Eosinophilic Esophagitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to test the effects (both good and bad) of high dose swallowed fluticasone propionate (Flovent) in subjects with eosinophilic esophagitis (EoE).

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Detailed Description

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Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Flovent 1760 mcg

Fluticasone propionate 880 mcg twice daily for 3 months

Group Type EXPERIMENTAL

Flovent

Intervention Type DRUG

1760 mcg daily

Placebo

Placebo twice daily for 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Flovent

1760 mcg daily

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Fluticasone propionate

Eligibility Criteria

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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 (rounded to nearest month) prior to endoscopy OR failure of histological improvement as defined by \< 1 eosinophil per HPF after 2 month (rounded to nearest 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 Fluticasone Propionate (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
* Concurrent or recent (within 3 months) use of systemic 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. Nasal glucocorticoids taken for EE are permitted.

Minimum Eligible Age

3 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No