Topical Steroid Treatment for Eosinophilic Esophagitis

May 1, 2012 updated by: Mayo Clinic

A Randomized Placebo-controlled Trial of Swallowed Fluticasone in Treatment of Eosinophilic Esophagitis

This was a randomized controlled trial of swallowed fluticasone vs. placebo for eosinophilic esophagitis. Eosinophilic esophagitis is an inflammatory condition in which the wall of the esophagus becomes filled with large numbers of eosinophils, a type of white blood cell. Patients who have this condition have difficulty in swallowing (dysphagia) solid food.

Prior to treatment the patients had biopsies of their esophagus and took questionnaires regarding their symptoms. Treatment was given for 6 weeks, after which biopsies were taken from the esophagus to measure any changes in the tissue from before treatment. The primary endpoint was improvement in dysphagia as measured by the validated Mayo Dysphagia Questionaire. Secondary outcomes included partial symptom response, and histologic (tissue) response to treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a double-blind randomized placebo controlled trial to evaluate the effect of aerosolized fluticasone therapy on symptomatic dysphagia and histologic eosinophilia in adults newly diagnosed with eosinophilic esophagitis (EoE). Participants were randomized to receive aerosolized swallowed fluticasone 880 mcg bid or placebo inhaler swallowed bid for 6 weeks.

Four mid esophageal biopsies were obtained from 10 cm above the squamo-columnar junction; then formalin-fixed and stained with hematoxylin and eosin. All esophageal biopsies were read and scored by a single expert gastrointestinal pathologist. The formalin-fixed paraffin-embedded esophageal biopsies were retrieved and underwent standard major basic protein (MBP) immunofluorescence staining. All special stain slides were then read and scored by another pathologist. 24-hour urine was collected for free cortisol by the standard technique. The original endoscopy was performed before the patient was enrolled in the trial by standard clinical technique. The endoscopy post treatment was done in the clinical research unit by the principal investigator.

Patients kept compliance logs that were reviewed at phone interviews at 2 and 4 weeks time and at the end of study evaluation. Ninety percent compliance was required for study inclusion.

At the end of 6 weeks, a 24-hour urine cortisol was done, and patients underwent a repeat endoscopy while still on treatment. Mid-esophageal biopsies were obtained and evaluated for eosinophil density and mast cell degranulation. At this visit the patients returned dysphagia and side effects questionnaires.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

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
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • > 20 eosinophils / hpf on biopsies from mid esophagus (hpf = high-powered field)
  • Abnormal dysphagia questionnaire (question 1a "yes", question 1c > "moderate" and question 2 > "less than once a week") on Mayo Dysphagia Questionnaire.

Exclusion Criteria:

  • Clinical evidence of infectious process potentially contributing to dysphagia (e.g., candidiasis, cytomegalovirus, herpes)
  • Systemic or topical steroid therapy for any reason over the past 3 months
  • Previous steroid treatment for Eosinophilic Esophagitis
  • Intolerance to steroid therapy in the past
  • Other cause of dysphagia identified at endoscopy (e.g., reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
  • Dilatation of esophagus at time of index endoscopy

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: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluticasone
Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
Drug: Fluticasone
Aerosolized swallowed fluticasone 880 mg twice a day
Other Names:
  • Veramyst
  • Flonase
Placebo Comparator: Placebo
Placebo inhaler swallowed bid for 6 weeks
Drug: Placebo
Placebo inhaler swallowed twice a day for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Complete Response to Dysphagia
Time Frame: 2 weeks
Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of "no" to the question "In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)?"
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Partial or Complete Response to Dysphagia
Time Frame: 2 weeks
Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of "no" to the question "In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)?" A partial symptom response was defined as an answer of yes to the above question and a decrease in severity of at least 2 levels, or a decrease in frequency of at least 1 level.
2 weeks
Number of Participants With Complete Histologic Response
Time Frame: 2 weeks
A complete histologic response was defined as >90% decrease in mean eosinophil count/high powered field
2 weeks

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Jeffrey A. Alexander, M.D., Mayo Clinic

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

Helpful Links

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

November 1, 2005

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 10, 2006

First Submitted That Met QC Criteria

January 10, 2006

First Posted (Estimate)

January 12, 2006

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1488-05

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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