Status:
COMPLETED
A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders
Lead Sponsor:
Marc Rothenberg
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
3-30 years
Phase:
PHASE3
Brief Summary
The purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the treatment of eosinophilic esophagitis (EE).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00266578
Start Date
October 1 2002
End Date
October 1 2012
Last Update
April 11 2013
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039