drugset / Trial / NCT01702701
Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2012-01
- Primary completion
- 2017-07-20
- Completion
- 2017-07-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluticasone | Other / unclassified | 440 ug | Oral |
| Comparator | Montelukast | Other / unclassified | 10 mg | Oral |