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Antihistamines in Eosinophilic Esophagitis (ATEE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04248712
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Dawn Francis, Mayo Clinic

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 : July 10, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


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




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 12 weeks ]
    Number of adverse events reported

  2. Change in maximum eosinophil count [ Time Frame: 12 weeks ]
    Calculated by maximum eosinophils per high-power field (eos/hpf) after therapy with antihistamines.


Secondary Outcome Measures :
  1. Change in symptoms of eosinophilic esophagitis, as measured by Dysphagia Symptom Questionnaire [ Time Frame: 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.

  2. Change in endoscopic response, as measured by the Endoscopic reference score [ Time Frame: 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.

  3. Change in histologic response [ Time Frame: 12 weeks ]
    Percentage of subjects with histologic response of ≤15 eos/hpf on biopsy at the lower and mid esophagus



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04248712


Contacts
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Contact: Bianca Axenfeld 904-953-3907 Axenfeld.Bianca@mayo.edu

Locations
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United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Dawn Francis, MD Mayo Clinic
Additional Information:
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Responsible Party: Dawn Francis, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04248712    
Other Study ID Numbers: 19-005510
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Loratadine
Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists