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

October 14, 2018 updated by: Mogens Bove

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Trollhättan, Sweden, SE46185
        • ENT dept, NÄL Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mometasone furoat
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
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.
Other Names:
  • Nasonex
Placebo Comparator: Placebo spray
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
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.
Other Names:
  • Nasonex comparator spray (APL)

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
"global health and social functioning dimensions" of SF-36
Time Frame: Two months
Difference in global health during treatment in active- as compared to placebo group.
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mogens Bove

Collaborators

Vastra Gotaland Region

Investigators

  • Principal Investigator: Mogens Bove, MD,PhD, Dept of ENT, Head&Neck Surgery, NÄL Hospital, Trollhättan, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 14, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGFOUREG-226361
  • 2012-005842-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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