Budesonide for Eosinophilic Esophagitis
(EOS-4 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called budesonide (a corticosteroid) to determine if a smaller dose taken twice daily is as effective as a larger dose taken once daily for treating eosinophilic esophagitis. Eosinophilic esophagitis is a condition where the esophagus becomes inflamed, leading to difficulty swallowing and discomfort. The trial aims to assess whether both dosing methods can achieve remission, reducing or eliminating symptoms and inflammation. Individuals with active eosinophilic esophagitis who experience symptoms may be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that budesonide orodispersible tablets are well-tolerated in treating eosinophilic esophagitis (EoE). Research indicates that these tablets can control the disease, with no signs of it, for up to 96 weeks without new safety issues. Patients have reported improved quality of life, and the treatment is effective for most people with EoE. One study found that after 6 weeks of treatment, 58% of patients showed no detectable signs of the disease. Overall, budesonide appears safe and has a good track record for treating this condition.12345
Why do researchers think this study treatment might be promising for eosinophilic esophagitis?
Unlike most treatments for eosinophilic esophagitis, which often involve liquid formulations or corticosteroids like fluticasone, the new budesonide treatment options are in the form of orodispersible tablets. These tablets dissolve directly in the mouth, which could enhance their ease of use and adherence compared to traditional methods. Arm A offers a once-daily 2 mg dosage, while Arm B presents a twice-daily 1 mg option, giving patients and doctors flexibility to tailor treatment to individual needs. Researchers are excited about these formulations because they offer a potentially more convenient and effective way to manage symptoms by directly targeting the esophagus.
What evidence suggests that this treatment might be an effective treatment for eosinophilic esophagitis?
Research has shown that budesonide orodispersible tablets effectively treat eosinophilic esophagitis (EoE), a condition characterized by inflammation of the esophagus. In one study, 58% of patients experienced symptom relief and esophageal healing after 6 weeks of treatment. Another study found that 81.9% of patients had symptom relief after 96 weeks. These tablets have also been shown to control symptoms for up to a year, with 73.5% of patients remaining in remission after 48 weeks. In this trial, participants will receive either a 2 mg orodispersible tablet once daily or a 1 mg orodispersible tablet twice daily. Overall, budesonide orodispersible tablets have shown promising results in managing EoE symptoms and maintaining remission.14567
Who Is on the Research Team?
Alfredo J Lucendo, MD, PhD
Principal Investigator
Department of Gastroenterology, Hospital General de Tomelloso, Spain
Are You a Good Fit for This Trial?
Adults aged 18-75 with a confirmed diagnosis of eosinophilic esophagitis (EoE), who are currently experiencing symptoms and have histological evidence of the disease. Participants must provide informed consent and women able to bear children need a negative pregnancy test.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 1 mg budesonide orodispersible tablets twice daily or 2 mg once daily for 6 weeks to induce clinico-pathological remission
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Budesonide
Trial Overview
The trial is testing if taking budesonide orodispersible tablets once daily (2 mg) is just as effective as taking them twice daily (1 mg each time) for inducing remission in EoE over six weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Budesonide 2 mg orodispersible tablet once daily
Budesonide 1 mg orodispersible tablet twice daily
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dr. Falk Pharma GmbH
Lead Sponsor
Citations
Effectiveness and Safety of Orodispersible Budesonide for ...
Our real-world data confirm that BOTs are effective in inducing clinical and histologic remission in most EoE patients. The drug has a good ...
Efficacy and Safety of Budesonide Orodispersible Tablets ...
Results: A total of 186 patients participated in the OLE up to 96 weeks. At week 96, 81.9% of patients had clinical remission, defined as an EoE ...
Efficacy and Safety of Budesonide Orodispersible Tablets ...
Budesonide orodispersible tablet (BOT) has been shown to be effective in eosinophilic esophagitis (EoE) for up to 1 year. This study investigates BOT in EoE ...
Evaluation of Efficacy, Safety and Patient' Satisfaction ...
A phase 3 trial showed the effectiveness of a 6-week treatment with new budesonide orodispersible tablet (BOT) to induce clinicohistologic remission in 58% of ...
Budesonide Orodispersible Tablets Maintain Remission in ...
Efficacy. The primary outcome—number of patients in remission after a 48-week maintenance treatment—was achieved in 50 of 68 (73.5%; P < ...
Efficacy and Safety of Budesonide Orodispersible Tablets ...
Mean EoE Quality of Life (EoE-QoL-A) Scale scores improved from 3.3 at OLE baseline to 3.5 at week 96. No new safety concerns were observed ...
Effectiveness and Safety of Orodispersible Budesonide for ...
Our real-world data confirm that BOTs are effective in inducing clinical and histologic remission in most EoE patients. The drug has a good ...
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