Phase 2
N=42
A Study of Flovent in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT00426283 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Percentage of Participants Who Attained Remission. — 65.2; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Flovent (Drug); Placebo (Other)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Marc Rothenberg, MD
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Attained Remission. |
65.2; 0 | — |
| SECONDARY Percent of Participants With Decreased Cortisol Levels After 3 Months |
17.4; 0 | — |
| SECONDARY Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent |
0.907; 0.541; 0.572 | — |
| SECONDARY EoE Score After 3 Months |
382; 152 | — |
| SECONDARY Association of Compliance With Therapy and Response to Flovent |
1.037 | — |
| SECONDARY Percent of Participants With Abdominal Pain After Therapy |
63; 50 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00426283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.