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Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Primary Purpose

Eosinophilic Esophagitis, Dysphagia

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Montelukast
Fluticasone
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GI Associates
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Montelukast

Fluticasone

Arm Description

patients will receive 10 mg po montelukast daily for 12 weeks.

patients will receive 440mcg fluticasone po bid for 12 weeks

Outcomes

Primary Outcome Measures

Improvement in Dysphagia symptom score

Secondary Outcome Measures

Improvement in esophageal histology counts of eosinophils/hpf

Full Information

First Posted
October 4, 2012
Last Updated
August 26, 2019
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT01702701
Brief Title
Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
Official Title
Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Withdrawn
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
July 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis, Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Montelukast
Arm Type
Active Comparator
Arm Description
patients will receive 10 mg po montelukast daily for 12 weeks.
Arm Title
Fluticasone
Arm Type
Active Comparator
Arm Description
patients will receive 440mcg fluticasone po bid for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Montelukast
Other Intervention Name(s)
Singulair
Intervention Description
montelukast 10mg po pill q day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Fluticasone
Other Intervention Name(s)
Flovent
Intervention Description
fluticasone 440mcg po q bid x 12 weeks
Primary Outcome Measure Information:
Title
Improvement in Dysphagia symptom score
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Improvement in esophageal histology counts of eosinophils/hpf
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Hogan, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nikhil Shastri, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Study Director
Facility Information:
Facility Name
GI Associates
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

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