Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Phase 3

Withdrawn

• Conditions: Eosinophilic Esophagitis; Dysphagia
• Interventions: Drug: Fluticasone; Drug: Montelukast

• Registration Number: NCT01702701
• Lead Sponsor: Medical College of Wisconsin

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-08
• Status Verified: 2016-01
• Primary Completion: 2017-07-20
• Study Completion: 2017-07-20
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluticasone	Fluticasone	patients will receive 440mcg fluticasone po bid for 12 weeks
Montelukast	Montelukast	patients will receive 10 mg po montelukast daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Improvement in Dysphagia symptom score	3 month

Secondary Outcome Measures

Name	Time	Method
Improvement in esophageal histology counts of eosinophils/hpf	3 month

Trial Locations

Locations (2)

GI Associates; 🇺🇸 Milwaukee, Wisconsin, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States