Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

November 2, 2012 updated by: Evan Dellon, University of North Carolina, Chapel Hill

Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE): Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis.

The purpose of this study is to conduct a clinical trial of two formulations of budesonide (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if medication contact time and distribution in the esophagus relates to treatment response. The investigators will also determine if there is systemic absorption of these topical steroids. The investigators hypothesize that tissue and symptom response will correlate with esophageal medication contact time and distribution, and that significant systemic absorption will not be seen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

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
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • New diagnosis of eosinophilic esophagitis (per 2007 consensus guidelines)

Exclusion Criteria:

  • Age < 18
  • Inability to read or understand English
  • Pregnant or nursing women
  • Previous allergic reactions to steroid medications
  • Current 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: inhaled/swallowed budesonide
Drug: inhaled/swallowed budesonide
medication will be nebulized and then swallowed
Active Comparator: viscous/swallowed budesonide
Drug: viscous/swallowed budesonide
viscous suspension of budesonide will be swallowed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue Eosinophil Counts
Time Frame: 8 weeks
Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adrenal Insufficiency
Time Frame: 8 weeks
Adrenal insufficiency as measured by a standard cortisol stimulation test (using 0.25 mg cosyntropin IV and baseline and 60 minute post-injection serum cortisol measurements) after treatment. A rise in serum cortisol concentration after to a peak of ≥18 mcg/dL was considered normal; a smaller rise than this was considered adrenal insufficiency.
8 weeks

Collaborators and Investigators

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

Sponsor

University of North Carolina, Chapel Hill

Collaborators

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (Estimate)

August 18, 2009

Study Record Updates

Last Update Posted (Estimate)

November 6, 2012

Last Update Submitted That Met QC Criteria

November 2, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRUSESOM0609

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.

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