Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis

Overview

The purpose of this study is to evaluate the efficacy of three doses of Florence oral suspension on changes of eosinophilic infiltration in esophageal biopsies.

Eligibility

Inclusion Criteria:

• Signed consent;
• Participants aged 18 years or more;
• Participants diagnosed with eosinophilic esophagitis, defined as:
  1. Presence of symptoms of esophageal dysfunction intermittently or continuously during previous week to the screening visit;
  2. Eosinophilic esophageal inflammation with ≥ 15 eosinophils/high-power field, in the screening endoscopy;
  3. Exclusion of other causes of esophageal eosinophilia.

Exclusion Criteria:

• Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
• Participants with a stricture on endoscopy that prevents passage of the endoscope;
• History of alcohol abuse or drug use;
• Use of concomitant therapies for any reason that may affect the assessment;
• History of gastroesophageal surgery;
• History of the abnormal gastrointestinal disorder;
• Another disorder that causes esophageal eosinophilia;
• Pregnancy or risk of pregnancy and lactating patients;
• Participants with known allergy, contraindication or hypersensitivity to the components of the medicine used in the clinical trial;
• Participation in clinical trial in the year prior to this study.