Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

August 26, 2019 updated by: Medical College of Wisconsin
This study will compare response to treatment of Eosinophilic Esophagitis with montelukast vs standard therapy fluticasone. Investigators hypothesize that montelukast is equally effective in treating symptoms and histology of EoE when compared to fluticasone. The study will be conducted at multiple sites with Medical College of Wisconsin as the coordinating site. After identification and recruitment all patients will be randomized (provider blinded) to one of two medications: montelukast 10mg po qday vs fluticasone 440mcg po bid. Patients will also complete a pretreatment, 6 week therapy and 12 week therapy questionaire. They will then undergo a repeat endoscopy to evaluate endoscopic and histologic response.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Eosinophilic esophagitis is an allergic condition of the esophagus with an incidence that is on the rise, and has limited treatment options. Current gold standard of treatment is with topical steroids (swallowed fluticasone). There is preliminary data that oral montelukast may prove to be effective in inducing and maintaining symptomatic along with histologic remission of this disease. Investigators will be comparing the effectiveness of singulair to swallowed fluticasone in inducing and maintaining histologic and symptomatic remission of eosinophilic esophagitis.

Study Type

Interventional

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
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • GI Associates

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:

  • Patients with a confirmed diagnosis of EoE on biopsy
  • with >15 eos per HPF
  • ages >18
  • Both male and Female.
  • Not pregnant

Exclusion Criteria:

  • pregnancy
  • patients receiving ongoing medical therapy for EoE
  • patients who underwent dilation in the last 12 weeks with improvement in symptoms
  • LA grade B or worse erosive esophagitis.
  • age < 18
  • nursing mothers
  • use of prohibited concomitant medications : budesonide-oral compounded liquid, fluticasone or montelukast.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Montelukast
patients will receive 10 mg po montelukast daily for 12 weeks.
Drug: Montelukast
montelukast 10mg po pill q day for 12 weeks
Other Names:
  • Singulair
Active Comparator: Fluticasone
patients will receive 440mcg fluticasone po bid for 12 weeks
Drug: Fluticasone
fluticasone 440mcg po q bid x 12 weeks
Other Names:
  • Flovent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in Dysphagia symptom score
Time Frame: 3 month
3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in esophageal histology counts of eosinophils/hpf
Time Frame: 3 month
3 month

Collaborators and Investigators

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

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Walter Hogan, MD, Medical College of Wisconsin
  • Study Director: Nikhil Shastri, MD, Medical College of Wisconsin

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

January 1, 2012

Primary Completion (Actual)

July 20, 2017

Study Completion (Actual)

July 20, 2017

Study Registration Dates

First Submitted

October 4, 2012

First Submitted That Met QC Criteria

October 4, 2012

First Posted (Estimate)

October 8, 2012

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCWEoEMVF

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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