| January 22, 2007 |
| August 26, 2009 |
| January 2007 |
| July 2011 (final data collection date for primary outcome measure) |
| 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. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: No ] |
| 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. |
| Complete list of historical versions of study NCT00426283 on ClinicalTrials.gov Archive Site |
- 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: three years (anticipated) ] [ Designated as safety issue: Yes ]
- To investigate the relationship between subject age, height, weight, allergic status and response to FP. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: No ]
- 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: three years (anticipated) ] [ Designated as safety issue: No ]
- To investigate subject compliance and response to FP. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: No ]
- To investigate the change in subject symptoms and response to FP. [ Time Frame: three years (anticipated) ] [ Designated as safety issue: No ]
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- 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.
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| |
| A Study of Flovent in Patients With Eosinophilic Esophagitis |
| A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis |
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). |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Eosinophilic Esophagitis |
- Drug: Flovent
- Other: Placebo
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| Experimental: Drug |
| |
| |
| Recruiting |
| 40 |
| July 2011 |
| July 2011 (final data collection date for primary outcome measure) |
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
- 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.
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| Both |
| 3 Years to 30 Years |
| No |
|
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| United States |
| |
| NCT00426283 |
| Marc E. Rothenberg, Cincinnati Children's Hospital |
| 06-10-07 |
| Children's Hospital Medical Center, Cincinnati |
|
| Principal Investigator: |
Marc E. Rothenberg, M.D., Ph.D. |
Children's Hospital Medical Center, Cincinnati |
|
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| Children's Hospital Medical Center, Cincinnati |
| August 2009 |