Antihistamines in Eosinophilic Esophagitis (ATEE)

A Phase II, Randomized, Placebo-controlled Study Evaluating the Efficacy of Antihistamines in the Treatment of Eosinophilic Esophagitis (the ATEE Study)

Researchers are assessing the safety and effectiveness of antihistamines in the treatment of eosinophilic esophagitis.

Study Overview

• Status: Terminated
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Drug: Famotidine; Drug: Loratadine; Drug: Placebo

Detailed Description

The purpose of this research is to determine if antihistamines are safe and effective for the treatment of eosinophilic esophagitis. Antihistamines are frequently used for the treatment of gastroesophageal reflux disease and allergic disorders, and we hypothesize they will be effective in the treatment of eosinophilic esophagitis as well. The two antihistamines used in this study are loratadine and famotidine.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients over the age of 18, male and female.
• Patients who carry the diagnosis of Eosinophilic Esophagitis (EoE) based on esophageal biopsies obtained within 6 months prior to enrollment (>15 eosinophils per hpf on at least 2 esophageal levels)
• Subjects must be able to give appropriate informed consent

Exclusion Criteria:

• Not willing or able to sign consent.
• Patients who have used topical or systemic corticosteroid therapy for any reason in the previous 6 weeks.
• Patients who have been treated with acid-suppressing medications (PPI or H2 receptor antagonists) in the previous 6 weeks.
• Patients on immunosuppressive or immunomodulating medications in the previous 6 weeks.
• Patients with known allergies or hypersensitivity to anti-histamines.
• Patients who have contraindications to the procurement of esophageal biopsies including patients who have known bleeding disorders, a history of bleeding diathesis, or who are currently using warfarin or clopidogrel.
• Patients who have a contraindication to the performance of an esophagogastroduodenoscopy (EGD) including previous cardiopulmonary arrest during an endoscopic procedure.
• Patients who are pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks.	Drug: Famotidine; 40 mg tab twice daily by mouth for 12 week duration; Drug: Loratadine; 10 mg tab once daily by mouth for 12 week duration
Placebo Comparator: Placebo Group; Participants receive Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks.	Drug: Placebo; Contains no active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number of adverse events reported	12 weeks
Change in Maximum Eosinophil Count	Calculated by maximum eosinophils per esophagogastroduodenoscopy (EGD) high-power field (eos/hpf) after therapy with antihistamines. As measured by the percentage of change in maximum eosinophil count from baseline to 12 weeks.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Symptoms of Eosinophilic Esophagitis, as Measured by Dysphagia Symptom Questionnaire	Measured by the self-reported Dysphagia Symptom Questionnaire (DSQ). The DSQ ranges from 0 to 10, with a lower score indicating less symptoms and a higher score indicating more symptoms.	12 weeks
Change in Endoscopic Response, as Measured by the Endoscopic Reference Score	Percentage of subjects with endoscopic response as measured by the Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS). The score ranges from 0 to 10, with a higher score indicating worse endoscopic findings of eosinophilic esophagitis.	12 weeks
Change in Histologic Response	Percentage of subjects with histologic response of ≤15 eos/hpf on biopsy at the lower and mid esophagus	12 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Dawn Francis, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Dermatologic Agents; Anti-Ulcer Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H1 Antagonists, Non-Sedating; Histamine H2 Antagonists; Famotidine; Loratadine
• Other Study ID Numbers: 19-005510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No