BUL1/EEA
Research type
Research Study
Full title
Double-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.
IRAS ID
184792
Contact name
Stephen Attwood
Contact email
Sponsor organisation
Dr. Falk Pharma GmbH
Eudract number
2014-001484-12
Duration of Study in the UK
1 years, 10 months, 29 days
Research summary
Eosinophilic esophagitis (EoE) is an allergic inflammatory condition of the esophagus (also known as the oesophagus or gullet), that involves eosinophils, a type of white blood cell. The disease often presents with dysphagia (difficulty swallowing), food impaction, regurgitation/vomiting, or decreased appetite. Currently EoE is diagnosed by the combination of clinical symptoms of esophageal dysfunction. Most commonly these are dysphagia and chest pain, and the histological finding of at least 15 eosinophils in one high power microscopic field from a tissue sample (biopsy) taken from the lining on the inside surface of the esophagus (the esophageal mucosa) that has been analysed by clinicians. In diagnosis, all clinical and pathologic (disease signs and symptoms) information should be taken into account and should not be interpreted in isolation.
Recent studies suggest that swallowing budesonide is highly effective in treating acute EoE. Further, that this might not be associated with toxicities common with the long term use of corticosteroid treatment delivered orally or via intramuscular injection.
The primary objective of this study it to assess the efficacy of 1 mg effervescent tablets of budesonide, taken twice a day, verses placebo in inducing a period of lesser or no symptoms of EoE (remission) as determined by an evaluation of the signs and symptoms manifesting in adult patients with active EoE.
The secondary objectives are to study safety and tolerability of the study treatment in the form of adverse events, laboratory parameters and also to assess patients’ quality of life.
The exploratory objective of the study is to study biomarkers of EoE.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0352
Date of REC Opinion
8 Dec 2015
REC opinion
Further Information Favourable Opinion