A Study of Flovent in Patients With Eosinophilic Esophagitis
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ClinicalTrials.gov Identifier: NCT00426283
Recruitment Status :
First Posted : January 24, 2007
Results First Posted : February 3, 2014
Last Update Posted : September 19, 2014
Information provided by (Responsible Party):
Marc Rothenberg, Children's Hospital Medical Center, Cincinnati
The Percentage of Participants Who Attained Remission. [ Time Frame: 3 months ]
Remission is considered achieved when the highest eosinophil count per high power field (hpf) in all esophageal biopsies is </= 1 eosinophil/hpf after 3 months of therapy.
Secondary Outcome 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: 3 months ]
To Investigate the Relationship Between Subject Age, Height, Weight, Allergic Status and Response to FP. [ Time Frame: 3 months ]
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: 3 months ]
To Investigate Subject Compliance and Response to FP. [ Time Frame: 3 months ]
To Investigate the Change in Subject Symptoms and Response to FP. [ Time Frame: 3 months ]
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Ages Eligible for Study:
3 Years to 30 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
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.