Trial Outcomes & Findings for Testing Effectiveness of Losartan in Patients With EoE With or Without a CTD (NCT NCT01808196)

NCT ID: NCT01808196

Last Updated: 2020-09-24

Results Overview

Percent of participants with peak eosinophil count \< 15 eosinophils/high power field (remission) in distal and proximal esophagus

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: 16 weeks after treatment
• Results posted on: 2020-09-24

Participant Flow

Participant milestones

Measure	Losartan Participants with eosinophilic esophagitis receive the Losartan daily Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Losartan Participants with eosinophilic esophagitis receive the Losartan daily Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.
Overall Study Lost to Follow-up	1

Baseline Characteristics

One subjects biopsies were not evaluated by research pathologist

Baseline characteristics by cohort

Measure	Losartan n=6 Participants Participants with eosinophilic esophagitis receive the Losartan daily Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.
Age, Continuous	13.4 years STANDARD_DEVIATION 5.2 • n=6 Participants
Sex: Female, Male Female	1 Participants n=6 Participants
Sex: Female, Male Male	5 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants
Race (NIH/OMB) White	6 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Peak Eosinophil Count Distal Peak Eosinophil Counts	108 eosinophils per high power field STANDARD_DEVIATION 86 • n=5 Participants • One subjects biopsies were not evaluated by research pathologist
Peak Eosinophil Count Proximal Peak Eosinophil Counts	40 eosinophils per high power field STANDARD_DEVIATION 37 • n=6 Participants • One subjects biopsies were not evaluated by research pathologist
Pediatric EoE Symptom Score	28 units on a scale STANDARD_DEVIATION 20 • n=5 Participants • Questionnaire not answered by one subject

PRIMARY outcome

Timeframe: 16 weeks after treatment

Percent of participants with peak eosinophil count < 15 eosinophils/high power field (remission) in distal and proximal esophagus

Outcome measures

Measure	Losartan n=6 Participants Participants with eosinophilic esophagitis receive Losartan daily Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.
Percent of Participants in Histologic Remission at 16 Weeks Distal Remission	17 percentage of participants
Percent of Participants in Histologic Remission at 16 Weeks Proximal Remission	17 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 16 weeks after treatment

Mean change in peak eosinophil count from baseline

Outcome measures

Measure	Losartan n=5 Participants Participants with eosinophilic esophagitis receive Losartan daily Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.
Change in Peak Eosinophil Count at 16 Weeks Change in Distal Peak Count	-43 eosinophils/high power field Standard Deviation 107
Change in Peak Eosinophil Count at 16 Weeks Change in Proximal Peak Count	3 eosinophils/high power field Standard Deviation 62

SECONDARY outcome

Timeframe: Baseline, 16 weeks after treatment

The PEESS V2.0 questionnaire captures EoE-specific symptoms (dysphagia, GERD, nausea/vomiting, and pain) as reported by parents. The range for PEESS v2.0 scores is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms. Scores were obtained at baseline and 16 weeks. Change in score is defined as total score at 16 weeks minus total score at baseline.

Outcome measures

Measure	Losartan n=5 Participants Participants with eosinophilic esophagitis receive Losartan daily Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.
Change in Pediatric EoE Symptom Score at 16 Weeks	-11 score on a scale Standard Deviation 12

Adverse Events

Losartan

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Losartan n=6 participants at risk Participants with eosinophilic esophagitis receive Losartan daily Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.
Gastrointestinal disorders Abdominal Pain	16.7% 1/6 • Number of events 2 • From consent to cessation of study which is approximately 24 weeks
Musculoskeletal and connective tissue disorders Back Pain	16.7% 1/6 • From consent to cessation of study which is approximately 24 weeks
Gastrointestinal disorders Food impaction	16.7% 1/6 • From consent to cessation of study which is approximately 24 weeks
Nervous system disorders Headache	16.7% 1/6 • From consent to cessation of study which is approximately 24 weeks
Gastrointestinal disorders Heartburn	16.7% 1/6 • From consent to cessation of study which is approximately 24 weeks
Ear and labyrinth disorders Hearing loss	16.7% 1/6 • From consent to cessation of study which is approximately 24 weeks

Additional Information

Pablo Abonia, MD

Cincinnati Children's Hospital Medical Center

Phone: 513-636-

Email: pablo.abonia@cchmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place