A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis


Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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).

What is involved?

On the first visit:
- You will meet with the study investigator and study coordinator
- Your vital signs and weight will be recorded.
- You will fill out.
- Two dysphagia questionnaires concerning swallowing problems.  This takes about 6 minutes.
- A side effects questionnaire. This takes about 2 minutes.
- A Patient Health Questionnaire. This takes about 2 minutes.
- A consent form. This takes about 5 minutes
During the study
- You are not to use any acid reducing medications
- You will receive your study medication by mail at the start of the study and at 12 weeks. The study medication (placebo or montelukast) will be given randomly (as in a flip of a coin)   you and your physician will not be informed of the selection.
- You will keep medication logs for compliance during the study.
- You will be contacted by phone or in person by the study coordinator at weeks 0, 2, 4, 8, 12, 16, 20, and 26.
- To review medication logs,
- To complete dysphagia questionnaire and a side affects questionnaire, and a patient health questionnaire
- You will take the study medication for 6 months time.

How long is the study?

6 months

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