A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders
Information source: Children's Hospital Medical Center, Cincinnati
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Eosinophilic Esophagitis
Intervention: Fluticasone Propionate (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Children's Hospital Medical Center, Cincinnati Official(s) and/or principal investigator(s):
Marc E. Rothenberg, M.D., Ph.D., Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati
Summary
The purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the
treatment of eosinophilic esophagitis (EE).
Clinical Details
Official title: Effect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled Trial
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Patients with EE treated with Flovent will demonstrate marked improvement in clinical symptoms, endoscopic findings, and histological abnormalities vs. those treated with placebo.
Secondary outcome: Patients demonstrating resolution of Flovent will have detectable changes in the expression of genes associated with eosinophilic infiltration by the esophageal mucosa.
Eligibility
Minimum age: 3 Years.
Maximum age: 30 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Signed informed consent for study by parent or guardian. Assent will be obtained from
all minors 11 years of age and older.
- Age older than or equal to 3 years and younger than or equal to 30 years
- Endoscopic findings consistent with EE (edema, furrowing, exudates, rings)
- Histological findings to include proliferation of basal layer and peak eosinophil
density ≥24 per high power field (400x). This degree of tissue eosinophilia has been
shown to correlate well with poor-responsiveness to acid suppression therapy,
suggesting it is a primary eosinophilic disease and not secondary to GERD[11].
- Allergy evaluation including skin-prick testing with multiple food antigens to insure
elimination diet is not indicated.
- If allergic to specific foods, option to be on a minimum 3 months of elimination diet
without detectable resolution by repeat endoscopy with biopsies demonstrating no
improvement to disease.
- Patients enrolled at CCHMC will be under the direct care of Dr. Putnam or any of the
other staff gastroenterologists at this institution who will supervise endoscopic
procedures. Patients may also be enrolled at institutions other than CCHMC, but the
diagnosis of EE must be validated by an expert pathologist in EE at CCHMC (Margaret
Collins, MD).
- 20 additional patients without EE will be enrolled as unaffected controls for purposes
of comparison with patients with EE. Enrollment pool will comprise patients
undergoing routine upper endoscopy and having no identifiable pathology.
Exclusion Criteria:
- Patients with history of poor tolerance to FP, patients unable to cooperate with use
of MDI, pregnant females, patients inhaling any corticosteroid for asthma, and
patients with concurrent or recent (within 3 months) use of systemic steroids.
Locations and Contacts
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, United States
Additional Information
Starting date: October 2002
Ending date: April 2012
Last updated: April 2, 2008
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