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Eosinophilic EsophagitisPhase 2NCT02113267

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

A Phase 2 study testing Mometasone furoate in people with Eosinophilic Esophagitis, run by Mogens Bove at 1 site in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Eosinophilic Esophagitis
What is being tested?
Mometasone furoate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSweden
Study dates
Apr 2014to Sep 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • ENT dept, NÄL Hospital

    Trollhättan, SE46185

Other trials in Sweden

About this 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

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.

Being tested
Mometasone furoate, Placebo
Keywords
esophagitis, eosinophils, allergy, inflammation, corticosteroids
Medical subject headings
Eosinophilic Esophagitis, Esophagitis, Hypersensitivity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mometasone furoateDrug

    Also called Nasonex

    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.

  • PlaceboDrug

    Also called Nasonex comparator spray (APL)

    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.

Study groups in NCT02113267
Study groupRoleWhat they receive
Mometasone furoatExperimentalMometasone 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.
Receives: Drug: Mometasone furoate
Placebo sprayPlacebo comparatorPlacebo. 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Watson Dysphagia Scale Score (WDS)

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

    Measured: Two months

Secondary outcomes (1)

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

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

    Measured: Two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionSep 2018
  4. Study completionSep 2018

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02113267
Sponsor's protocol ID
VGFOUREG-226361
Other IDs
2012-005842-39
Status last verified
Oct 2018
First submitted
10 Apr 2014
Last updated
17 Oct 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19504557

  • 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.

    PubMed 17135307

  • 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.

    PubMed 21493413

  • 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.

    PubMed 17413601

  • 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.

    PubMed 21477849

  • 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.

    PubMed 20682320

  • 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.

    PubMed 21593463

  • 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.

    PubMed 33831327

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mometasone furoate in people with Eosinophilic Esophagitis, run by Mogens Bove at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Combination slow recruitment, short shelf life for placebo and insufficient funding for further drug production (probably anyway sufficient number included).). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Watson Dysphagia Scale Score (WDS) (time frame: Two months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02113267, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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