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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast | Active Comparator | patients will receive 10 mg po montelukast daily for 12 weeks. |
|
| Fluticasone | Active Comparator | patients will receive 440mcg fluticasone po bid for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | montelukast 10mg po pill q day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Dysphagia symptom score | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in esophageal histology counts of eosinophils/hpf | 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter Hogan, MD | Medical College of Wisconsin | Principal Investigator |
| Nikhil Shastri, MD | Medical College of Wisconsin | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GI Associates | Milwaukee | Wisconsin | 53226 | United States | ||
| Medical College of Wisconsin |
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Fluticasone | Drug | fluticasone 440mcg po q bid x 12 weeks |
|
|
| Milwaukee |
| Wisconsin |
| 53226 |
| United States |
| D005759 |
| Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |