Trial of Montelukast in Eosinophilic Esophagitis

Mayo Clinic

Status and phase

Completed

Phase 1

Conditions

Eosinophilic Esophagitis

Treatments

Drug: Montelukast/ Singulair

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00511316

06-003373

Details and patient eligibility

About

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.

Full description

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.

Enrollment

41 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).