Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

NCT ID: NCT01702701

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2017-07-20

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.

Conditions

Eosinophilic Esophagitis; Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Montelukast

patients will receive 10 mg po montelukast daily for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Montelukast

Intervention Type: DRUG

montelukast 10mg po pill q day for 12 weeks

Fluticasone

patients will receive 440mcg fluticasone po bid for 12 weeks

Group Type: ACTIVE_COMPARATOR

Fluticasone

Intervention Type: DRUG

fluticasone 440mcg po q bid x 12 weeks

Interventions

Montelukast

montelukast 10mg po pill q day for 12 weeks

Intervention Type: DRUG

Fluticasone

fluticasone 440mcg po q bid x 12 weeks

Intervention Type: DRUG

Other Intervention Names

Singulair; Flovent

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter Hogan, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Nikhil Shastri, MD

Role: STUDY_DIRECTOR

Medical College of Wisconsin

Locations

GI Associates

Milwaukee, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

MCWEoEMVF

Identifier Type: -

Identifier Source: org_study_id