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

April 10, 2013 updated by: Marc Rothenberg

Effect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histologic remission
Time Frame: 5 years
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Furrowing, Epithelial hyperplasia, clinical symptoms
Time Frame: 5 years
Secondary outcome measures included presence of endoscopic furrowing, presence of epithelial hyperplasia, and presence of clinical symptoms.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marc Rothenberg

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 15, 2005

First Submitted That Met QC Criteria

December 15, 2005

First Posted (Estimate)

December 19, 2005

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-9-9
  • FAAN (Food Allergy and Anaphylaxis Network)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eosinophilic Esophagitis

Clinical Trials on Fluticasone Propionate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe