Clinical trial NCT00426283: A Study of Flovent in Patients With Eosinophilic Esophagitis
Official title: A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic Esophagitis
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2007-01-24
Enrollment: 42
Sex: ALL
Minimum age (years): 3
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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 (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.

Primary outcomes:
measure: Percentage of Participants Who Attained Remission.
timeFrame: 3 months
Secondary outcomes:
measure: Percent of Participants With Decreased Cortisol Levels After 3 Months
timeFrame: 3 months
measure: Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent
timeFrame: 3 months
measure: EoE Score After 3 Months
timeFrame: 3 months
measure: Association of Compliance With Therapy and Response to Flovent
timeFrame: 3 months
measure: Percent of Participants With Abdominal Pain After Therapy
timeFrame: 3 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: The Children's Hospital of Denver
state: Colorado
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Marc E. Rothenberg, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Butz BK, Wen T, Gleich GJ, Furuta GT, Spergel J, King E, Kramer RE, Collins MH, Stucke E, Mangeot C, Jackson WD, O'Gorman M, Abonia JP, Pentiuk S, Putnam PE, Rothenberg ME. Efficacy, dose reduction, and resistance to high-dose fluticasone in patients with eosinophilic esophagitis. Gastroenterology. 2014 Aug;147(2):324-33.e5. doi: 10.1053/j.gastro.2014.04.019. Epub 2014 Apr 22.