A Study of Flovent in Patients With Eosinophilic Esophagitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00426283
• Date of registration: 22/01/2007
• Prospective Registration: No
• Primary sponsor: Marc Rothenberg, MD
• Public title: A Study of Flovent in Patients With Eosinophilic Esophagitis
• Scientific title: A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis
• Date of first enrolment: January 2007
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00426283
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Marc E. Rothenberg, M.D., Ph.D.
• Affiliation: Children's Hospital Medical Center, Cincinnati

Key inclusion & exclusion 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.



Age minimum: 3 Years
Age maximum: 30 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Drug: Flovent

Other: Placebo

Primary Outcome(s)

Percentage of Participants Who Attained Remission. [Time Frame: 3 months]

Secondary Outcome(s)

EoE Score After 3 Months [Time Frame: 3 months]

Association of Compliance With Therapy and Response to Flovent [Time Frame: 3 months]

Association of Subject Age, Body Mass Index Z-score, and Allergic Status to Response to Flovent [Time Frame: 3 months]

Percent of Participants With Abdominal Pain After Therapy [Time Frame: 3 months]

Percent of Participants With Decreased Cortisol Levels After 3 Months [Time Frame: 3 months]

Secondary ID(s)

06-10-07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/02/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00426283