Tomelloso

Researchers are investigating the effectiveness and tolerability of two different dosing schedules of budesonide orodispersible tablets for adults with active eosinophilic esophagitis, a condition characterized by inflammation of the esophagus. This Phase III trial aims to demonstrate that taking 1 mg twice daily is not inferior to taking 2 mg once daily in inducing clinical and pathological remission over six weeks. Participants will be randomly assigned to receive either 1 mg budesonide tablets twice daily or 2 mg once daily, with tablets taken 30 minutes after a meal. The treatment period lasts six weeks, during which the effect of the medication on inducing remission will be evaluated. Throughout the study, participants will be monitored for remission through clinical assessments and histological evaluations after six weeks of treatment. Safety and tolerability will also be assessed to understand the impact of the medication schedule. The total study duration includes this six-week treatment phase, focusing on inducing remission and observing patient response.