title: A New Formulation of Oral Viscous Budesonide in Treating Paediatric Eosinophilic Oesophagitis: A Pilot Study.
abstract: Oral viscous budesonide is a recent therapeutic option for eosinophilic oesophagitis (EoE) compared with dietary restriction and inhaled steroids. This single-centre, open-label, not blinded study aims to evaluate the efficacy and safety of a new, preprepared oral viscous budesonide suspension (PVB) in children and adolescents with EoE.
  
  
  
  We treated 36 children with PVB (29 boys; median age 12 years) with EoE diagnosed according to European Society for Paediatric Gastroenterology Hepatology and Nutrition guidelines. Patients <150 and >150 cm height received 2 and 4 mg PVB daily, respectively, for 12 weeks. Upper gastrointestinal endoscopy was performed at baseline, after 12 weeks of therapy and 24 weeks after the end of therapy. Baseline and post-treatment scores were calculated for symptoms, endoscopy, and histology. Serum cortisol was performed at baseline, 12, and 36 weeks.
  
  
  
  At the end of PVB trial, endoscopy showed macroscopic remission in 32 patients (88.9%), whereas at histology median pre- and post-treatment peak eosinophil count/high power field (HPF) markedly decreased from 42.2 (range: 15-100) to 2.9 (range: 0-30); moreover, mean symptom and histology scores impressively improved compared with baseline (P < 0.01). At 24 weeks after the end of PVB therapy, endoscopy showed oesophageal relapse in 21 patients (58.3%), whereas 15 (41.7%) were still in remission. Seven children (19.4%) with positive multichannel intraluminal impedance-pH were treated also with proton pump inhibitors. No significant difference between pre-/post-treatment morning cortisol levels occurred.
  
  
  
  The new PVB suspension presented in the present study is effective and safe for treating children with proven EoE. Larger placebo-controlled clinical trials would provide more information about dosing, efficacy, and long-term safety of this formulation, specifically designed for the oesophagus.
authors.affiliation: *Department of Paediatrics and Childhood Neuropsychiatry, Paediatric Gastroenterology and Liver Unit †Department of Paediatrics and Childhood Neuropsychiatry, PICU ‡Department of Radiological Sciences, Oncology, and Anatomical Pathology, Sapienza-University of Rome, Rome, Italy §Unit of Pediatric Gastroenterology, Integrated Pediatric Hospital, Centro Hospitalar de São João, Porto, Portugal.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Oliva
authors.forename: Danilo
authors.initials: D
authors.lastname: Rossetti
authors.forename: Paola
authors.initials: P
authors.lastname: Papoff
authors.forename: Antonio
authors.initials: A
authors.lastname: Tiberti
authors.forename: Paolo
authors.initials: P
authors.lastname: Rossi
authors.forename: Sara
authors.initials: S
authors.lastname: Isoldi
authors.forename: Jorge
authors.initials: J
authors.lastname: Amil Dias
authors.forename: Sandra
authors.initials: S
authors.lastname: Lucarelli
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cucchiara
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D057765:Eosinophilic Esophagitis / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D013535:Suspensions; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D013535:Suspensions; D019819:Budesonide