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

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ClinicalTrials.gov Identifier: NCT02113267
Recruitment Status : Terminated (Combination slow recruitment, short shelf life for placebo and insufficient funding for further drug production (probably anyway sufficient number included).)
First Posted : April 14, 2014
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Mogens Bove, Vastra Gotaland Region

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: Mometasone furoate Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 2014
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018


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 Name: 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 Name: Nasonex comparator spray (APL)




Primary Outcome Measures :
  1. Watson Dysphagia Scale Score (WDS) [ Time Frame: Two months ]
    Difference in WDS score during treatment in active as compared to placebo group.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. "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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113267


Locations
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Sweden
ENT dept, NÄL Hospital
Trollhättan, Sweden, SE46185
Sponsors and Collaborators
Mogens Bove
Vastra Gotaland Region
Investigators
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Principal Investigator: Mogens Bove, MD,PhD Dept of ENT, Head&Neck Surgery, NÄL Hospital, Trollhättan, Sweden

Publications:

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Responsible Party: Mogens Bove, Associate Professor, Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02113267     History of Changes
Other Study ID Numbers: VGFOUREG-226361
2012-005842-39 ( EudraCT Number )
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

Keywords provided by Mogens Bove, Vastra Gotaland Region:
esophagitis
eosinophils
allergy
inflammation
corticosteroids

Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents