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CompletedNCT00266578Updated Apr 11, 2013

A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders

A Phase 3 interventional study of Fluticasone Propionate in Eosinophilic Esophagitis, sponsored by Marc Rothenberg. Completed at 1 site in United States. Open to participants aged 3 Years to 30 Years. Per ClinicalTrials.gov, last updated 2013-04-11.

Sponsored by Marc Rothenberg · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
3 Years to 30 Years
Sex
All
01

Study summary

The purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the treatment of eosinophilic esophagitis (EE).

02

Conditions studied

  • Eosinophilic Esophagitis

Keywords

  • Eosinophilic Esophagitis
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In context

Esophagitis

322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.

This study's enrollment of 30 is below the median of 66 across 215 interventional studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

Marc Rothenberg is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Interventions

  • DrugFluticasone Propionate

    Flovent vs. placebo daily for 3 months

06

What researchers measure

Primary outcomes

  1. Histologic remission

    Histologic remission,defined by a peak eosinophil count of less than/equal to 1 eosinophil in all 400 fields in both the proximal and distal esophagus.

    Time frame: 5 years

Secondary outcomes

  1. Furrowing, Epithelial hyperplasia, clinical symptoms

    Secondary outcome measures included presence of endoscopic furrowing, presence of epithelial hyperplasia, and presence of clinical symptoms.

    Time frame: 5 years

07

Study locations

1 site
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229-3039, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00266578
Lead sponsor
Marc Rothenberg
Responsible party
Marc Rothenberg (MD, PhD, Children's Hospital Medical Center, Cincinnati) — Sponsor-investigator
First posted
Dec 19, 2005
Start date
Oct 2002
Primary completion
Nov 2006
Completion
Oct 2012
Last update
Apr 11, 2013

Study contacts

Marc E. Rothenberg, M.D., Ph.D.
principal investigator · Children's Hospital Medical Center, Cincinnati
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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