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

Eosinophilic Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02113267
• Other study ID #: VGFOUREG-226361
• Secondary ID: 2012-005842-39
• Status: Terminated
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: September 2018

Study information

• Verified date: October 2018
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	ENT dept, NÄL Hospital	Trollhättan

Sponsors (2)

Lead Sponsor	Collaborator
Mogens Bove	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (7)

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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	"global health and social functioning dimensions" of SF-36	Difference in global health during treatment in active- as compared to placebo group.	Two months
Primary	Watson Dysphagia Scale Score (WDS)	Difference in WDS score during treatment in active as compared to placebo group.	Two months
Secondary	The EORTC QLQ-OES18 dysphagia scale, the eating scale and choking item	Difference in score in active- as compared to placebo- group	Two months