NCT02113267

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Mogens Bove · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2014-04-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2014-04-14
• Last updated: 2018-10-17

Locations

1 site across 1 country: Sweden