Antihistamines in Eosinophilic Esophagitis (ATEE)
Primary Purpose
Eosinophilic Esophagitis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Famotidine
Loratadine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Group
Placebo Group
Arm Description
Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks.
Participants receive Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks.
Outcomes
Primary Outcome Measures
Adverse Events
Number of adverse events reported
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.
Secondary Outcome Measures
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.
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.
Change in Histologic Response
Percentage of subjects with histologic response of ≤15 eos/hpf on biopsy at the lower and mid esophagus
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04248712
Brief Title
Antihistamines in Eosinophilic Esophagitis
Acronym
ATEE
Official Title
A Phase II, Randomized, Placebo-controlled Study Evaluating the Efficacy of Antihistamines in the Treatment of Eosinophilic Esophagitis (the ATEE Study)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
July 10, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers are assessing the safety and effectiveness of antihistamines in the treatment of eosinophilic esophagitis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Participants receive Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Famotidine
Intervention Description
40 mg tab twice daily by mouth for 12 week duration
Intervention Type
Drug
Intervention Name(s)
Loratadine
Intervention Description
10 mg tab once daily by mouth for 12 week duration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Contains no active ingredient
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number of adverse events reported
Time Frame
12 weeks
Title
Change in Maximum Eosinophil Count
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Symptoms of Eosinophilic Esophagitis, as Measured by Dysphagia Symptom Questionnaire
Description
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.
Time Frame
12 weeks
Title
Change in Endoscopic Response, as Measured by the Endoscopic Reference Score
Description
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.
Time Frame
12 weeks
Title
Change in Histologic Response
Description
Percentage of subjects with histologic response of ≤15 eos/hpf on biopsy at the lower and mid esophagus
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Francis, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Antihistamines in Eosinophilic Esophagitis
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