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

NCT02113267 | Terminated Phase 2 DMC

• 2 other identifiers: VGFOUREG-2263612012-005842-39
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Keywords

esophagitis; eosinophils; allergy; inflammation; corticosteroids

Outcome Measures

Primary Outcomes (1)

• Watson Dysphagia Scale Score (WDS)

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

  Two months

Secondary Outcomes (1)

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

  Two months

Other Outcomes (1)

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

  Two months

Study Arms (2)

Mometasone furoat

EXPERIMENTAL

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

Placebo spray

PLACEBO COMPARATOR

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

Interventions

Mometasone furoate DRUG

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.

Also known as: Nasonex

Mometasone furoat

Placebo DRUG

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.

Also known as: Nasonex comparator spray (APL)

Placebo spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Mogens Bove: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

ENT dept, NÄL Hospital

Trollhättan, SE46185, Sweden

Location

Related Publications (8)

• 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.

  PMID: 19504557 BACKGROUND

• 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.

  PMID: 17135307 BACKGROUND

• 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.

  PMID: 21493413 BACKGROUND

• 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.

  PMID: 17413601 BACKGROUND

• 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.

  PMID: 21477849 BACKGROUND

• 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.

  PMID: 20682320 BACKGROUND

• 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.

  PMID: 21593463 BACKGROUND

• 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.

  PMID: 33831327 DERIVED

MeSH Terms

Conditions

Eosinophilic Esophagitis; Esophagitis; Hypersensitivity; Inflammation

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mogens Bove, MD,PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 14, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

SE (1)