Completed
A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis
What is being tested
Flovent
+ Placebo
DrugOther
Who is being recruted
Digestive System Diseases+10
+ Eosinophilia
+ Esophageal Diseases
From 3 to 30 Years
+12 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: January 2007
Summary
Principal SponsorMarc Rothenberg, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2007
Actual date on which the first participant was enrolled.The purpose of this study is to test the effects (both good and bad) of high dose swallowed fluticasone propionate (Flovent) in subjects with eosinophilic esophagitis (EoE).
Official TitleA Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis
Principal SponsorMarc Rothenberg, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
42 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 3 to 30 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Digestive System DiseasesEosinophiliaEsophageal DiseasesEsophagitisGastroenteritisGastrointestinal DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLeukocyte DisordersEosinophilic Esophagitis
Criteria
5 inclusion criteria required to participate
Signed informed consent for study by subject, or parent/guardian if subject is a minor. Assent will be obtained from all minors 11 years of age and older.
Histological findings on esophageal biopsy to include peak eosinophil density ≥ 24 per high power field (400x) in the proximal or distal esophagus validated by a pathologist at CCHMC.
Allergy evaluation including skin-prick testing with multiple food antigens to ensure elimination diet is not indicated.
Have undergone a minimum 3 months of elimination diet as indicated by skin-prick testing without detectable resolution by repeat endoscopy with biopsies demonstrating persistent EE OR subject/parental refusal to follow elimination diet. If the subject/parent refuses the elimination diet, they are eligible for this study.
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7 exclusion criteria prevent from participating
History of poor tolerance to Fluticasone Propionate (FP), as defined as multiple episodes of oral candidiasis, hypothalamic-pituitary-adrenal axis suppression as evidenced by signs of Cushing syndrome, headaches, or increased respiratory infections during exposure to Flovent
Unable to cooperate with use of MDI
Pregnant females
Concurrent or recent (within 3 months) use of systemic corticosteroids.
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalFluticasone propionate 880 mcg twice daily for 3 months
Group II
PlaceboPlacebo twice daily for 3 months
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Suspended
The Children's Hospital of Denver
Aurora, United StatesOpen The Children's Hospital of Denver in Google MapsSuspended
Cincinnati Children's Hospital Medical Center
Cincinnati, United StatesSuspended
Children's Hospital of Philadelphia
Philadelphia, United StatesSuspended
University of Utah
Salt Lake City, United StatesCompleted4 Study Centers