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Antihistamine

Treatment Group for Eosinophilic Esophagitis (ATEE Trial)

Phase 2
Waitlist Available
Led By Dawn Francis, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial is testing if antihistamines, specifically loratadine and famotidine, are safe and effective for treating eosinophilic esophagitis. This condition involves inflammation of the esophagus due to an excess of certain white blood cells. The antihistamines aim to reduce this inflammation by blocking histamine, which causes allergic reactions. Loratadine has been shown to reduce allergen-induced nasal symptoms and inflammation in allergic rhinitis.

Eligible Conditions
  • Eosinophilic Esophagitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Change in Maximum Eosinophil Count
Secondary study objectives
Change in Endoscopic Response, as Measured by the Endoscopic Reference Score
Change in Histologic Response
Change in Symptoms of Eosinophilic Esophagitis, as Measured by Dysphagia Symptom Questionnaire

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment GroupExperimental Treatment2 Interventions
Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks.
Group II: Placebo GroupPlacebo Group1 Intervention
Participants receive Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Famotidine
2005
Completed Phase 4
~1700
Loratadine
2011
Completed Phase 4
~5330

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,307 Previous Clinical Trials
2,962,398 Total Patients Enrolled
25 Trials studying Eosinophilic Esophagitis
1,490 Patients Enrolled for Eosinophilic Esophagitis
Dawn Francis, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital Jacksonville
University Of Colorado School Of Medicine (Medical School)
Mayo Grad School Med/Mayo Fndn (Residency)
~0 spots leftby Oct 2025
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