Recruiting

Fluticasone vs. Omeprazole

Sponsor:

Claire Daniels

Code:

NCT03781596

Conditions

Eosinophilic Esophagitis

Eligibility Criteria

Sex: All

Age: 6 - 60

Healthy Volunteers: Not accepted

Interventions

Retrospective evaluation of endoscopy prior to study drug

Symptom Survey

Medication Compliance Phone Call

Endoscopy while on study drug

Symptom Survey

Study Details

Brief summary:

The purpose of this study is to evaluate the efficacy of combination therapy with omeprazole and swallowed fluticasone vs fluticasone therapy and placebo in the treatment of Eosinophilic Esophagitis (EoE) in children and adults. This study will be a double-blinded, randomized controlled trial. The primary outcome measured will be histologic assessment of esophageal tissue biopsies measuring number of eosinophils per high power field (eos/hpf). Secondary outcomes will be endoscopic findings and symptomatic changes following therapy using validated endoscopic scoring measures and participant surveys, respectively.

Conditions

Eosinophilic Esophagitis

Study ID

NCT03781596

Start date

Oct 2, 2018

Status verified date

Dec, 2018

Completion date

Oct 2, 2022

Anticipated

Primary completion date

Oct 2, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • age 6 to 60 years old
  • DEERS (defense enrollment eligibility reporting system) eligible
  • diagnosis of eosinophilic esophagitis

Exclusion Criteria:

  • Outside of age range
  • Co-existing inflammatory gastroenterologic condition such as celiac disease, eosinophilic esophagitis, or inflammatory bowel disease.
  • Concurrent use of oral steroids
  • Pregnancy
  • Refusal to undergo endoscopy

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Fluticasone and omeprazole

These patients will be prescribed swallowed fluticasone and omeprazole to be taken together for the 8 week period. Dosing will be based on weight and age. Primary outcome measure will be the change in esophageal biopsy histology, or number of eosinophils per high powered field, from week 0 to week 8. Secondary outcomes will include changes in the following variables between week 0 and 8: eotaxin staining of the esophageal biopsy tissue, endoscopic scoring from photos of the esophagus obtained during endoscopy, and symptom scoring based on surveys.

placebo comparator: Fluticasone and placebo

These patients will be prescribed swallowed fluticasone and a placebo medication that appears identical to omeprazole to be taken together for an 8 week period. Dosing will be based on weight and age. Primary outcome measure will be the change in esophageal biopsy histology, or number of eosinophils per high powered field, from week 0 to week 8. Secondary outcomes will include changes in the following variables between week 0 and 8: eotaxin staining of the esophageal biopsy tissue, endoscopic scoring from photos of the esophagus obtained during endoscopy, and symptom scoring based on surveys.

Interventions

Retrospective evaluation of endoscopy prior to study drug

Once enrolled, the patient's original endoscopy will be evaluated including the images from the EGD and the biopsies for eotaxin 3 staining and eosinophilic burden.

Symptom Survey

Patient will complete symptom survey prior to starting the study drugs.

Medication Compliance Phone Call

The patient will receive a phone call at 4 weeks to evaluate medication compliance including the number on the inhaler and the number of pills remaining in the container.

Endoscopy while on study drug

Endoscopy will be performed after 8 weeks of therapy. Endoscopic scoring will be assigned and the histology will be evaluated, including eotaxin 3 staining. The change in eosinophil count and eotaxin staining will be measured.

Symptom Survey

The patient will complete a symptom survey after 8 weeks on the study drugs, and the change in survey score will be measured.

Fluticasone

Participants in the experimental and placebo arms will be given swallowed fluticasone for an 8 week course. Doses determined by age and weight.

Omeprazole

The participants in the experimental arm will be given oral omprazole capsules for an 8 week period (along with the swallowed fluticasone). Doses determined by age and weight.

Placebo oral capsule

The participants in the placebo arm will be given placebo capsules for an 8 week period (along with the swallowed fluticasone). Number of pills determined by age and weight (to match omeprazole dosing).

Primary outcome measure

  • Change in esophageal eosinophilia [ Time Frame: There will be one at week 0 and week 8. ]

Central Contacts and Locations

Central contacts

Steve B Min, M.D.

301-295-4959steve.b.min.mil@mail.mil

Claire P Daniels, M.D.

301-295-4959claire.p.daniels.mil@mail.mil

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Claire P Daniels, M.D.

443-904-3353claire.p.daniels.mil@mail.mil

More Information

Sponsor

Claire Daniels

Last update posted

Dec 20, 2018

Last verified

Dec, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Claire Daniels on 2018-12-20.