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A Study of Flovent in Patients With Eosinophilic Esophagitis

M

Marc Rothenberg, MD

Status and phase

Completed
Phase 2

Conditions

Eosinophilic Esophagitis

Treatments

Drug: Flovent
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00426283
06-10-07

Details and patient eligibility

About

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).

Enrollment

42 patients

Sex

All

Ages

3 to 30 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

42 participants in 2 patient groups, including a placebo group

Flovent 1760 mcg
Experimental group
Description:
Fluticasone propionate 880 mcg twice daily for 3 months
Treatment:
Drug: Flovent
Placebo
Placebo Comparator group
Description:
Placebo twice daily for 3 months
Treatment:
Other: Placebo

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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