None listed
Conditions
Brief summary
Eosinophilic oesophagitis (EoE) is a common cause of dysphagia and is now the leading cause of food bolus impaction (FBO) in Western countries. The most effective treatment for EoE is budesonide orodispersible tablet (BOT - Jorveza™). A new topical corticosteroid called Jorveza became available in May of 2022 and demonstrated efficacy with complete resolution of EoE at 1mg orally twice daily in 80% of recipients. Many patients and clinicians attempt dose reduction to 1mg orally once daily with the hope of improving convenience, compliance and reducing side effects, yet there is no evidence that reducing total dose or reducing dose frequency will maintain remission. A randomised trial of Budesonide Orodispersible tablet (BOT) at 2mg orally once daily compared to 1mg orally once daily in patients with EoE who initially respond to 1mg orally twice daily is thus proposed.
Interventions
Patients who have been treated with the standard dose of Budesonide 2mg tablet (taken orally twice daily) and have achieved remission—defined as fewer than 5 eosinophils per high-power field (HPF)—will be eligible for recruitment into the study. Randomisation will take place at the baseline visit, with treatment commencing 48 hours after randomisation. Participants will receive Budesonide 2mg tablet orally once daily for 12 weeks.
After 12 weeks of treatment, participants will be reviewed by th
Patients who have been treated with the standard dose of Budesonide 2mg tablet (taken orally twice daily) and have achieved remission—defined as fewer than 5 eosinophils per high-power field (HPF)—will be eligible for recruitment into the study. Randomisation will take place at the baseline visit, with treatment commencing 48 hours after randomisation. Participants will receive Budesonide 2mg tablet orally once daily for 12 weeks. After 12 weeks of treatment, participants will be reviewed by their treating gastroenterologist, including assessment of endoscopy and biopsy results. If their condition remains stable (fewer than 15 eosinophils per HPF), they will continue with the current dose. If their condition worsens (greater than 15 eosinophils per HPF), they will return to the standard dose. Participants may withdraw from the study at any time if they choose to do so. Participants will be asked to estimate their compliance with the treatment at the time of each of their clinical visits (initial clinic visit and prior to follow up endoscopy) using a Likert Score (visual rank 1-10). In this real-world intention to treat study, patients that describe poor compliance will still continue the study.
Sponsors
Northern Adelaide Local Health Network
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who meet all the following criteria: - Present with food bolus obstruction (FBO) or dysphagia - Diagnosed with EoE according to endoscopy and biopsy showing >15 eosinophils per high power field in any one oesophageal location (peak count). - Currently taking pantoprazole 40mg orally twice daily with a demonstrated complete response at endoscopy and oesophageal biopsy with <5 eosinophils per high power field (HPF)
Exclusion criteria
Exclusion criteria will comprise any of the following conditions or factors: • Coexistent medical conditions that could cause oesophageal eosinophilia (e.g. primary hypereosinophilic syndrome, organ transplant recipient, connective tissue disorder, crohn’s disease) • Medications that could cause oesophageal eosinophilia (e.g. antiepileptic, clozapine) • Medications that could suppress the immune system and decrease eosinophil count (e.g,systemic corticosteroids, immunusupressants such as methotrexate or azathioprine, biological agents such as anti – TNF) • Usual residence is a forensic facility • Intellectual disability • Pregnancy
Outcome results
None listed