Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2012 |
| End Date: | August 2016 |
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.
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.
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.
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.
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.
We found this trial at
2
sites
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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