Antihistamines in 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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

~1220

Loratadine

2011

Completed Phase 4

~5330