Eosinophilic Esophagitis
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGMontelukast/ Singulair
20 mg daily for six months
DRUGPlacebo
Placebo 20 mg daily for 6 months
Sponsors
Merck Sharp & Dohme LLC
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| evaluate effectiveness of oral montelukast in treatment of EE. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| evaluate safety of montelukast in eosinophilic esophagitis | 6 months |
Countries
United States
Outcome results
None listed