Budesonide for Eosinophilic esophagitis

Inclusion criteria

• {"criterion_text":"- Age 4-18 years"}
• {"criterion_text":"- Diagnosis of EoE (>15 eosinophils/HPF in oesophageal biopsies) with failure to respond to proton pump inhibitors or with flare-up after discontinuation of proton pump inhibitors. The diagnosis must have been confirmed by endoscopy with oesophageal, gastric and duodenal biopsies. Subjects with a peak intraepithelial eosinophil count of ≥15/HPF (standard size 0.3 mm2) and no significant gastric or duodenal pathology will be histologically eligible for the study"}
• {"criterion_text":"- Subjects with previous topical steroid therapy (non-response or flare-up after discontinuation)"}
• {"criterion_text":"- Informed written parental/legal representative consent and verbal consent according to the maturity of the child"}
• {"criterion_text":"- Female subjects of childbearing age after urine pregnancy test. Sexual abstinence is an acceptable method of contraception, if in line with the subject's normal habits. The use of contraceptive methods will also be required for the duration of the study. Acceptable contraceptive methods are combined low-dose oral hormonal contraceptives; male or female condom with or without spermicide; male condom hood, diaphragm or sponge with spermicide, a combination of male condom with spermicide hood, diaphragm or sponge with spermicide (double barrier)"}

Exclusion criteria

• {"criterion_text":"- Presence of other non-EoE gastrointestinal diseases (e.g. eosinophilic gastroenteritis/colitis, chronic inflammatory bowel disease, or coeliac disease)"}
• {"criterion_text":"- Use of proton pump inhibitors within 2 weeks of baseline endoscopy"}
• {"criterion_text":"- Severe renal failure"}
• {"criterion_text":"- Hepatic failure (Prothrombin time (PT) >15 s or INR >1.5 with evidence of encephalopathy or PT >20 s or INR >2 without encephalopathy)"}
• {"criterion_text":"- Existence of haemorrhagic diathesis, use of anti-coagulant drugs"}
• {"criterion_text":"- Need for topical or systemic steroids for other conditions during the study period"}
• {"criterion_text":"- Current pregnancy or breastfeeding"}
• {"criterion_text":"- Psychiatric conditions that reduce compliance with the protocol"}
• {"criterion_text":"- Primary or secondary immune deficiency"}
• {"criterion_text":"- Ongoing chronic or acute infectious diseases (viral, bacterial, parasitic)"}
• {"criterion_text":"- Previous hypersensitivity reactions to budesonide or excipients"}
• {"criterion_text":"- Allergy to nickel, soya, gluten"}
• {"criterion_text":"- Diabetes or other chronic organic diseases"}
• {"criterion_text":"- Oral or oesophageal candidiasis"}
• {"criterion_text":"- Oesophageal stenosis"}
• {"criterion_text":"- Use of steroids (topical or systemic) within 4 weeks of baseline endoscopy, including combined hormonal contraceptives (except low-dose)"}

Primary endpoints

• {"endpoint_text":"- Reduction/disappearance of eosinophil count in oesophageal mucosa (<15 EoE/HPF) after viscous budesonide therapy (T12)","definition_or_measurement_approach":"Histological assessment on oesophageal biopsies: reduction to <15 eosinophils per high-power field (standard size 0.3 mm2) measured after treatment at timepoint T12."}

Secondary endpoints

• {"endpoint_text":"- Reduction of the symptomatic score calculated after therapy (T12)","definition_or_measurement_approach":"Change in the study's symptomatic score measured after therapy at T12 (specific scoring instrument not detailed in the provided documents)."}
• {"endpoint_text":"- Reduction in endoscopic score calculated after therapy (T12)","definition_or_measurement_approach":"Change in endoscopic score measured after therapy at T12 (specific endoscopic scoring system not detailed in the provided documents)."}
• {"endpoint_text":"- Monitoring and collection of adverse events (AEs) and severe adverse events (SAEs) (T6; T12)","definition_or_measurement_approach":"Collection and reporting of AEs and SAEs at timepoints T6 and T12 according to standard safety reporting procedures."}

Italy

Earliest CTIS Part Ii Submission Date

13-11-2024

Latest Decision Or Authorization Date

11-12-2024

Processing Time Days

28

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

University Hospital Consorziale Policlinico

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Co-sponsors

• University Of Bari Aldo Moro