Eosinophilic EsophagitisPhase 2ATEENCT04248712
Antihistamines in Eosinophilic Esophagitis
A Phase 2 study testing Famotidine and Loratadine in people with Eosinophilic Esophagitis, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are assessing the safety and effectiveness of antihistamines in the treatment of eosinophilic esophagitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Famotidine and Loratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2020to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Famotidine, Loratadine, Placebo
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamotidineDrug
40 mg tab twice daily by mouth for 12 week duration
LoratadineDrug
10 mg tab once daily by mouth for 12 week duration
PlaceboDrug
Contains no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks. Receives: Drug: Famotidine; Drug: Loratadine |
| Placebo Group | Placebo comparator | Participants receive Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of adverse events reported
Measured: 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.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 12 weeks
Change in Histologic Response
Percentage of subjects with histologic response of ≤15 eos/hpf on biopsy at the lower and mid esophagus
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start10 Jul 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn Francis, Mayo Clinic
- Investigators
- Dawn Francis, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248712
- Sponsor's protocol ID
- 19-005510
- Acronym
- ATEE
- Status last verified
- Nov 2022
- First submitted
- 28 Jan 2020
- Last updated
- 20 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Placebo-controlled Study Evaluating the Efficacy of Antihistamines in the Treatment of Eosinophilic Esophagitis (the ATEE Study)
- ClinicalTrials.gov ID
- NCT04248712
- Acronym / sponsor ID
- ATEE / 19-005510
- Conditions
- Eosinophilic Esophagitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Posted 20 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Famotidine, Drug: LoratadineParticipants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks. |
| Placebo Group | Placebo comparator | Drug: PlaceboParticipants receive Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Famotidine40 mg tab twice daily by mouth for 12 week duration | Drug | Treatment Group |
| Loratadine10 mg tab once daily by mouth for 12 week duration | Drug | Treatment Group |
| PlaceboContains no active ingredient | Drug | Placebo Group |
Primary outcome
Adverse Events
Time frame: 12 weeks
Number of adverse events reported
Change in Maximum Eosinophil Count
Time frame: 12 weeks
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.
3 secondary outcomes
Change in Symptoms of Eosinophilic Esophagitis, as Measured by Dysphagia Symptom Questionnaire
Time frame: 12 weeks
Change in Endoscopic Response, as Measured by the Endoscopic Reference Score
Time frame: 12 weeks
Change in Histologic Response
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
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Natural History and Genetics of Food Allergy and Related Conditions
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A Study in Adult Participants With EoE to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 20 mg Up to 24 Weeks
Eosinophilic Esophagitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Francis, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Famotidine and Loratadine in people with Eosinophilic Esophagitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022; AzTrials last refreshed its copy on 1 Nov 2026.