Double-blind, Randomized, Non-inferiority Trial Comparing 2 mg Once Daily Versus 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis

What this Trial Is About

Researchers are evaluating the effectiveness of budesonide orodispersible tablets in adult patients with active eosinophilic esophagitis (EoE). The study aims to demonstrate that a 6-week treatment with 1 mg tablets taken twice daily is not less effective than 2 mg tablets taken once daily in inducing clinico-pathological remission. This phase III trial is randomized and double-blind to compare these two dosing regimens. Participants receive either 2 mg budesonide tablets once daily or 1 mg tablets twice daily for six weeks. Following this, there is an open-label extension phase where participants may take 0.5 mg or 1 mg budesonide tablets twice daily. The tablets are taken 30 minutes after a meal. The study monitors how well these treatments induce remission and their tolerability. During the study, participants are regularly assessed for histological remission after six weeks, which is the primary outcome. Clinical remission after six weeks is also measured as a secondary outcome. The study involves close monitoring to ensure adherence to treatment and to evaluate safety. Overall participation lasts through the initial treatment and the open-label extension phase, with multiple visits for evaluation.

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE