Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis

• Status: Completed
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose: To determine whether oral viscous budesonide (OVB) or fluticasone metered dose inhaler (MDI) most effectively treats EoE by improving histologic findings and symptoms, which medication provides a more durable treatment response, and whether biomarkers can predict treatment response.

Participants: A total of up to 200 16-80 year old patients with a new diagnosis of eosinophilic esophagitis (EoE) who are referred for upper endoscopy will be consented with a target of 122 randomized.

Procedures: This will be a prospective, randomized, double-blind, double-dummy, clinical trial comparing OVB to fluticasone MDI for treatment of EoE. This overall study design will generate data for all three Aims

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Budesonide; Fluticasone

Criteria

Inclusion criteria are as follows:

• Age: 16 - 80 years

• Subject is having a clinically indicated endoscopy for suspicious EoE and has been on twice daily (BID) proton pump inhibitor (PPI) for at least 8 weeks OR New diagnosis of EoE as per consensus guidelines. Cases must have symptoms of dysphagia, persistent esophageal eosinophilia (≥ 15 eosinophils in at least one high-power field) after 8 weeks of treatment with a twice daily proton-pump inhibitor, and other competing causes of esophageal eosinophilia excluded.

Exclusion criteria are as follows:

• Medical instability that precludes safely performing upper endoscopy

• Ongoing or recent symptoms of intestinal bleeding (throwing up blood, passing blood in the stool)

• Concomitant eosinophilic gastroenteritis

• Esophageal narrowing or stricturing that will not allow a standard 9 mm upper endoscopy scope to pass

• Cancer in the esophagus, stomach, or intestine

• Previous esophageal surgery

• Esophageal varices (dilated blood vessels in the esophagus)

• Current use of blood thinners like Plavix or Coumadin that are not stopped prior to endoscopy procedures

• Any corticosteroid exposure within the 4 weeks prior to their baseline endoscopic exam. Exclusionary corticosteroid exposure is defined as any swallowed topical steroids for EoE or systemic steroids for any condition within the four weeks prior to the baseline endoscopy. Corticosteroids used for asthma or intranasal corticosteroids are not an exclusion and are allowable.

• Pregnancy

• Inability to read or understand English