Official Title: “A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Montelukast/ Singulair
  • 20 mg daily for six months
• Drug: Placebo
  • Placebo 20 mg daily for 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Drug
  • 20 mg montelukast daily for 6 months
• Placebo Comparator: Placebo
  • 20 mg daily placebo

Primary Measures

• evaluate effectiveness of oral montelukast in treatment of EE.
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• evaluate safety of montelukast in eosinophilic esophagitis
  • Time Frame: 6 months
    Safety Issue?: Yes

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mayo Clinic

Overall Clinical Trial Officials and Contacts

Jeffery A. Alexander, M.D. Principal Investigator Mayo Clinic  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00511316

Study ID Number: 06-003373

ClinicalTrials.gov Identifier: NCT00511316

Health Authority: United States: Institutional Review Board

Mayo Clinic Clinical Trials