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

Primary Purpose

Eosinophilic Esophagitis

Status

Terminated

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Mometasone furoate

Placebo

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring esophagitis, eosinophils, allergy, inflammation, corticosteroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ENT dept, NÄL Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mometasone furoat

Placebo spray

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Watson Dysphagia Scale Score (WDS)

Difference in WDS score during treatment in active as compared to placebo group.

Secondary Outcome Measures

The EORTC QLQ-OES18 dysphagia scale, the eating scale and choking item

Difference in score in active- as compared to placebo- group

Full Information

NCT ID

NCT02113267

First Posted

April 10, 2014

Last Updated

October 14, 2018

Sponsor

Mogens Bove

Collaborators

Vastra Gotaland Region

1. Study Identification

Unique Protocol Identification Number

NCT02113267

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Terminated

Why Stopped

Combination slow recruitment, short shelf life for placebo and insufficient funding for further drug production (probably anyway sufficient number included).

Study Start Date

April 2014 (Actual)

Primary Completion Date

September 2018 (Actual)

Study Completion Date

September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mogens Bove

Collaborators

Vastra Gotaland Region

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eosinophilic Esophagitis

Keywords

esophagitis, eosinophils, allergy, inflammation, corticosteroids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mometasone furoat

Arm Type

Experimental

Arm Description

Arm Title

Placebo spray

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Mometasone furoate

Other Intervention Name(s)

Nasonex

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Nasonex comparator spray (APL)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Watson Dysphagia Scale Score (WDS)

Description

Difference in WDS score during treatment in active as compared to placebo group.

Time Frame

Two months

Secondary Outcome Measure Information:

Title

The EORTC QLQ-OES18 dysphagia scale, the eating scale and choking item

Description

Difference in score in active- as compared to placebo- group

Time Frame

Two months

Other Pre-specified Outcome Measures:

Title

"global health and social functioning dimensions" of SF-36

Description

Difference in global health during treatment in active- as compared to placebo group.

Time Frame

Two months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mogens Bove, MD,PhD

Organizational Affiliation

Dept of ENT, Head&Neck Surgery, NÄL Hospital, Trollhättan, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

ENT dept, NÄL Hospital

City

Trollhättan

ZIP/Postal Code

SE46185

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

19504557

Citation

Bergquist H, Bove M. Eosinophilic esophagitis in adults: An ear, nose, and throat perspective. Laryngoscope. 2009 Aug;119(8):1467-71. doi: 10.1002/lary.20255.

Results Reference

background

PubMed Identifier

17135307

Citation

Ronkainen J, Talley NJ, Aro P, Storskrubb T, Johansson SE, Lind T, Bolling-Sternevald E, Vieth M, Stolte M, Walker MM, Agreus L. Prevalence of oesophageal eosinophils and eosinophilic oesophagitis in adults: the population-based Kalixanda study. Gut. 2007 May;56(5):615-20. doi: 10.1136/gut.2006.107714. Epub 2006 Nov 29.

Results Reference

background

PubMed Identifier

21493413

Citation

Larsson H, Bergquist H, Bove M. The incidence of esophageal bolus impaction: is there a seasonal variation? Otolaryngol Head Neck Surg. 2011 Feb;144(2):186-90. doi: 10.1177/0194599810392655.

Results Reference

background

PubMed Identifier

17413601

Citation

Kerlin P, Jones D, Remedios M, Campbell C. Prevalence of eosinophilic esophagitis in adults with food bolus obstruction of the esophagus. J Clin Gastroenterol. 2007 Apr;41(4):356-61. doi: 10.1097/01.mcg.0000225590.08825.77.

Results Reference

background

PubMed Identifier

21477849

Citation

Liacouras CA, Furuta GT, Hirano I, Atkins D, Attwood SE, Bonis PA, Burks AW, Chehade M, Collins MH, Dellon ES, Dohil R, Falk GW, Gonsalves N, Gupta SK, Katzka DA, Lucendo AJ, Markowitz JE, Noel RJ, Odze RD, Putnam PE, Richter JE, Romero Y, Ruchelli E, Sampson HA, Schoepfer A, Shaheen NJ, Sicherer SH, Spechler S, Spergel JM, Straumann A, Wershil BK, Rothenberg ME, Aceves SS. Eosinophilic esophagitis: updated consensus recommendations for children and adults. J Allergy Clin Immunol. 2011 Jul;128(1):3-20.e6; quiz 21-2. doi: 10.1016/j.jaci.2011.02.040. Epub 2011 Apr 7.

Results Reference

background

PubMed Identifier

20682320

Citation

Straumann A, Conus S, Degen L, Felder S, Kummer M, Engel H, Bussmann C, Beglinger C, Schoepfer A, Simon HU. Budesonide is effective in adolescent and adult patients with active eosinophilic esophagitis. Gastroenterology. 2010 Nov;139(5):1526-37, 1537.e1. doi: 10.1053/j.gastro.2010.07.048. Epub 2010 Aug 1.

Results Reference

background

PubMed Identifier

21593463

Citation

Bergquist H, Larsson H, Johansson L, Bove M. Dysphagia and quality of life may improve with mometasone treatment in patients with eosinophilic esophagitis: a pilot study. Otolaryngol Head Neck Surg. 2011 Oct;145(4):551-6. doi: 10.1177/0194599811409857. Epub 2011 May 18.

Results Reference

background

PubMed Identifier

33831327

Citation

Tytor J, Larsson H, Bove M, Johansson L, Bergquist H. Topically applied mometasone furoate improves dysphagia in adult eosinophilic esophagitis - results from a double-blind, randomized, placebo-controlled trial. Scand J Gastroenterol. 2021 Jun;56(6):629-634. doi: 10.1080/00365521.2021.1906314. Epub 2021 Apr 8.

Results Reference

derived

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

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