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Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01702701
Enrollment
0
Registered
2012-10-08
Start date
2012-01-31
Completion date
2017-07-20
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Eosinophilic Esophagitis

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.

Interventions

DRUGMontelukast

montelukast 10mg po pill q day for 12 weeks

DRUGFluticasone

fluticasone 440mcg po q bid x 12 weeks

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Improvement in Dysphagia symptom score3 month

Secondary

MeasureTime frame
Improvement in esophageal histology counts of eosinophils/hpf3 month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026