NCT01702701

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
Last Updated

August 28, 2019

Status Verified

January 1, 2016

Enrollment Period

5.6 years

First QC Date

October 4, 2012

Last Update Submit

August 26, 2019

Conditions

Eosinophilic EsophagitisDysphagia

Outcome Measures

Primary Outcomes (1)

  • Improvement in Dysphagia symptom score

    3 month

Secondary Outcomes (1)

  • Improvement in esophageal histology counts of eosinophils/hpf

    3 month

Study Arms (2)

Montelukast

ACTIVE COMPARATOR

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

Drug: Montelukast

Fluticasone

ACTIVE COMPARATOR

patients will receive 440mcg fluticasone po bid for 12 weeks

Drug: Fluticasone

Interventions

MontelukastDRUG

montelukast 10mg po pill q day for 12 weeks

Also known as: Singulair
Montelukast
FluticasoneDRUG

fluticasone 440mcg po q bid x 12 weeks

Also known as: Flovent
Fluticasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GI Associates

Milwaukee, Wisconsin, 53226, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Eosinophilic EsophagitisDeglutition Disorders

Interventions

montelukastFluticasone

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Walter Hogan, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

  • Nikhil Shastri, MD

    Medical College of Wisconsin

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2012

First Posted

October 8, 2012

Study Start

January 1, 2012

Primary Completion

July 20, 2017

Study Completion

July 20, 2017

Last Updated

August 28, 2019

Record last verified: 2016-01

Locations

US(2)