Mometasone-furoate for Treatment of Eosinophilic Esophagitis - a Randomized Placebo Controlled Study.
Status:
Terminated
Trial end date:
2018-09-01
Target enrollment:
Participant gender:
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.