Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
Information source: Medical College of Wisconsin
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Eosinophilic Esophagitis; Dysphagia
Intervention: Montelukast (Drug); Fluticasone (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Medical College of Wisconsin Official(s) and/or principal investigator(s): Walter Hogan, MD, Principal Investigator, Affiliation: Medical College of Wisconsin Nikhil Shastri, MD, Study Director, Affiliation: Medical College of Wisconsin
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.
Clinical Details
Official title: Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Improvement in Dysphagia symptom score
Secondary outcome: Improvement in esophageal histology counts of eosinophils/hpf
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
GI Associates, Milwaukee, Wisconsin 53226, United States
Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States
Additional Information
Starting date: January 2012
Last updated: August 5, 2015
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