Mometasone-furoate for Treatment of Eosinophilic Esophagitis - a Randomized Placebo Controlled Study.

Study Overview
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Brief Summary
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Background: Eosinophilic esophagitis ( EoE ) is a disease entity which has been properly recognized only within the past two decades.(1) A prevalence of nearly 1% means that almost 20,000 people in the Region of Western Sweden may be affected.(2 ) The main symptom is swallowing difficulty and food may be stuck, which typically require acute hospital care with operational action under general anesthesia.( 3,4 ) The standard treatment today is local treatment with steroids by mouth several times a day for a few weeks.( 5 ) In adults and large teenagers, there is only one randomized study which has shown that budesonide has a significant effect exaggerating that of placebo. However, the main end-point in this study was the degree of tissue inflammation.(6) In a separate study using validated questionnaires , we have shown that patients with EoE have distinct organ-specific symptoms and a lowered quality of life . These symptoms nearly disappeared, after treatment with mometasone furoate. However, as that study was not randomized or placebo controlled no causal conclusions could be drawn regarding the treatment effect, but the method of validated questionnaires proved sensitive to changes in symptomatology.(7) Purpose The primary purpose of this study is to evaluate the effect of local steroid treatment with mometasone furoate on swallowing problems in patients with EoE . Secondarily, to evaluate the effect on patient quality of life and the presence of side effects.

Official Title
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Treatment of Eosinophilic Esophagitis With Mometason Furoat Aerosol: a Randomised, Placebo-controled Phase II Study for Evaluation of Treatment Effect on Group Level Including Symtom Questionnaires

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Drug: Mometasone furoate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years Newly diagnosed cases with diagnostic criteria for EoE (ie at least 15 eosinophils per high power field (Magnification 10 times 40 = x400) in any field of view in any esophageal biopsy and concurrent symptoms of esophageal dysfunction mainly dysphagia. Women of childbearing age may participate provided that the pregnancy is not planned , and that contraceptive use during therapy. The investigator will arrange a free pregnancy test must be performed within 1 week before treatment and be negative. Participation requires oral and written informed and signed consent form (see patient information and consent forms). Exclusion Criteria: Local infection of the pharynx or esophagus , such as fungal, bacterial or viral infection Active or latent tuberculosis in respiratory tract Recent history of major trauma or major surgery Recent significant infection or other physical stress Signs or suspicion of dehydration History of injury, illness or surgery in the adrenals or pituitary Pharynx or esophagussurgery or other trauma in the esophagus (incl. foreign body with a sharp object ) where healing has not taken place. (in case of doubt to be assessed by esophago - gastroscopy. Planned elective surgery during treatment Pregnancy, ongoing or planned Women of childbearing potential not using preventives during the study period Glaucoma Hypersensitivity to any component in the treatments Systemic or local steroid treatment last 4 months Contraindication to steroid therapy ( immune deficiency or suppression , stomach ulcers, diabetes) Medications that affect oesophageal motility (cisapride, erythromycin ) during the treatment period . PPIs during or up to 2 weeks before the treatment period Other cause of dysphagia (cancer, connective tissue disease , neurological disease ) Volunteer who can not consent to the study or complete a questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mometasone furoat<br>Mometasone furoate monohydrate. 4 spray doses à 50 micrograms by mouth to be swallowed 4 times daily after meals (9) with no eating or drinking allowed 30 minutes after intake. Duration of treatment is 8 weeks. | Drug: Mometasone furoate<br>* 4 spray doses à 50 micrograms by mouth to be swallowed 4 times daily after meals with no eating or drinking allowed 30 minutes after intake. Duration of treatment is 8 weeks.<br>* Other names: Nasonex;|
| Placebo Comparator: Placebo spray<br>Placebo. 4 spray doses à 50 micrograms by mouth to be swallowed 4 times daily after meals (9) with no eating or drinking allowed 30 minutes after intake. Duration of treatment is 8 weeks. | Drug: Placebo<br>* 4 spray doses à 50 micrograms by mouth to be swallowed 4 times daily after meals (9) with no eating or drinking allowed 30 minutes after intake. Duration of treatment is 8 weeks.<br>* Other names: Nasonex comparator spray (APL);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Watson Dysphagia Scale Score (WDS) | Difference in WDS score during treatment in active as compared to placebo group. | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The EORTC QLQ-OES18 dysphagia scale, the eating scale and choking item | Difference in score in active- as compared to placebo- group | Two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophagitis, eosinophils, allergy, inflammation, corticosteroids