ATEE: Antihistamines in Eosinophilic Esophagitis

Sponsor

Mayo Clinic (Other)

Overall Status

Terminated

CT.gov ID

NCT04248712

Collaborator

(none)

Enrollment

Location

Arms

17.7

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Eosinophilic Esophagitis	Drug: Famotidine Drug: Loratadine Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 10, 2020

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Adverse Events [12 weeks]
Number of adverse events reported
Change in maximum eosinophil count [12 weeks]
Calculated by maximum eosinophils per high-power field (eos/hpf) after therapy with antihistamines.

Secondary Outcome Measures

Change in symptoms of eosinophilic esophagitis, as measured by Dysphagia Symptom Questionnaire [12 weeks]
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.
Change in endoscopic response, as measured by the Endoscopic reference score [12 weeks]
Percentage of subjects with endoscopic response as measured by the EoE Endoscopic Reference Score (EREFS). The score ranges from 0 to 10, with a higher score indicating worse endoscopic findings of eosinophilic esophagitis.
Change in histologic response [12 weeks]
Percentage of subjects with histologic response of ≤15 eos/hpf on biopsy at the lower and mid esophagus

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients over the age of 18, male and female.
Patients who carry the diagnosis of 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Dawn Francis, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Dawn Francis, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT04248712

Other Study ID Numbers:

19-005510

First Posted:

Jan 30, 2020

Last Update Posted:

Apr 6, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Esophagitis

Eosinophilic Esophagitis

Loratadine

Famotidine

Study Results

No Results Posted as of Apr 6, 2022