Antihistamines in Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

— ATEE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04248712
• Other study ID #: 19-005510
• Status: Terminated
• Phase: Phase 2
• Start date: July 10, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• Famotidine
40 mg tab twice daily by mouth for 12 week duration
• Loratadine
10 mg tab once daily by mouth for 12 week duration
• Placebo
Contains no active ingredient

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of adverse events reported	12 weeks
Primary	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	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
Secondary	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
Secondary	Change in Histologic Response	Percentage of subjects with histologic response of =15 eos/hpf on biopsy at the lower and mid esophagus	12 weeks

External Links

•   Mayo Clinic Clinical Trials