Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Eosinophilic Esophagitis Dysphagia |
| Intervention | Drug: Montelukast Drug: Fluticasone |
| Phase | Phase 3 |
| Sponsor | Medical College of Wisconsin |
| Responsible Party | Medical College of Wisconsin |
| ClinicalTrials.gov Identifier | NCT01702701 |
| First Received | October 4, 2012 |
| Last Updated | November 21, 2012 |
| Last verified | October 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 4, 2012 |
|---|---|
| Last Updated Date | November 21, 2012 |
| Start Date | January 2012 |
| Estimated Primary Completion Date | August 2015 |
| Current Primary Outcome Measures | Improvement in Dysphagia symptom score [Time Frame: 3 month] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Improvement in esophageal histology counts of eosinophils/hpf [Time Frame: 3 month] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone |
|---|---|
| Official Title | Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone |
| 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 Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Montelukast montelukast 10mg po pill q day for 12 weeks Other Names: SingulairDrug: Fluticasone fluticasone 440mcg po q bid x 12 weeks Other Names: Flovent |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 100 |
| Estimated Completion Date | August 2015 |
| Estimated Primary Completion Date | December 2014 |
| 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01702701 |
|---|---|
| Other Study ID Numbers | MCWEoEMVF |
| Has Data Monitoring Committee | No |
| Information Provided By | Medical College of Wisconsin |
| Study Sponsor | Medical College of Wisconsin |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Walter Hogan, MD Medical College of WisconsinStudy Director: Nikhil Shastri, MD Medical College of Wisconsin |
| Verification Date | October 2012 |
Locations[ + expand ][ + ]
| Medical College of Wisconsin | Milwaukee, Wisconsin, United States, 53226 |
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| GI Associates | Milwaukee, Wisconsin, United States, 53226 |