Trial of Montelukast in Eosinophilic Esophagitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2015-09-30

Brief Summary

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Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of dysphagia and food impaction in patients with EE.

Also evaluate tolerance and safety of oral montelukast in treatment of EE.

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Detailed Description

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We will randomize in a double blind manner 60 consecutive consenting patients being evaluated at the three Mayo Clinic Medical Centers with EE to montelukast 20mg daily or placebo daily for six months? time. Patients will be in remission after treatment with topical fluticasone therapy before enrollment. Patients will fill out a validated dysphagia and side effect questionnaire before, during, and at the end of therapy.

Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Drug

20 mg montelukast daily for 6 months

Group Type EXPERIMENTAL

Montelukast/ Singulair

Intervention Type DRUG

20 mg daily for six months

Placebo

20 mg daily placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 20 mg daily for 6 months

Interventions

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Montelukast/ Singulair

20 mg daily for six months

Intervention Type DRUG

Placebo

Placebo 20 mg daily for 6 months

Intervention Type DRUG

Other Intervention Names

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Singulair

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* \> 14 eosinophils / hpf on biopsies from mid esophagus within the 6 months.
* Abnormal dysphagia questionnaire (Question 1a yes, question 1c \>/= mild and question 2 \>/= less than once a week) prior to topical steroid treatment. This questionnaire has recently been validated.
* Normal dysphagia questionnaire after topical steroid treatment (Having an answer of no to question 1a: Have you had trouble swallowing, not associated with other cold symptoms? over the past two weeks since having completed the swallowed steroid treatment).

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes