Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2019-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Purpose: To determine whether oral viscous budesonide (OVB) or fluticasone metered dose inhaler (MDI) most effectively treats EoE by improving histologic findings and symptoms, which medication provides a more durable treatment response, and whether biomarkers can predict treatment response.

Participants: A total of up to 200 16-80 year old patients with a new diagnosis of eosinophilic esophagitis (EoE) who are referred for upper endoscopy will be consented with a target of 122 randomized.

Procedures: This will be a prospective, randomized, double-blind, double-dummy, clinical trial comparing OVB to fluticasone MDI for treatment of EoE. This overall study design will generate data for all three Aims

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

NCT00961233

Eosinophilic Esophagitis

COMPLETED NA

Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Eosinophilic Esophagitis

NCT02280616

Eosinophilic Esophagitis

COMPLETED PHASE2

Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)

NCT05444543

Eosinophilic Esophagitis

COMPLETED PHASE4

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

NCT06596252

Eosinophilic Esophagitis

RECRUITING PHASE3

A Study of Flovent in Patients With Eosinophilic Esophagitis

NCT00426283

Eosinophilic Esophagitis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This will be a prospective, randomized, double-blind, double-dummy, clinical trial comparing oral viscous budesonide (OVB) to fluticasone metered dose inhaler (MDI) for treatment of EoE. A total of 122 subjects aged 16-80 years old will be randomized in a 1:1 fashion to one of two active treatment arms: OVB + placebo inhaler or fluticasone MDI + placebo slurry.

In the first arm, subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily. The OVB is a slurry equivalent to what is used clinically: 1 mg/4 mL aqueous budesonide mixed with 10 g of sucralose. Rather than asking the subjects to mix the slurry on their own and risk inconsistent formulations, the University of North Carolina (UNC) investigational drug pharmacy (IDP) will provide pre-mixed OVB to all patients. The IDP will also provide placebo inhalers to all patients. The dose for OVB has been chosen because it is the most commonly studied dose, including one prior study led by this Principal Investigator, so we can accurately estimate response rates.

In the second arm, subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB. The UNC investigational drug pharmacy (IDP) will provide the fluticasone MDIs and pre-mixed placebo slurries to all patients. The dose for fluticasone MDI has been chosen because this is the most commonly used dose in adolescents and adults with EoE, so effect estimates are also available.

For both arms, the slurry will be administered first, the MDI will be administered 15 minutes later, and patients will take nothing by mouth for an additional 30 minutes.

Subjects will receive 8 weeks of treatment and will then be monitored for up to 52 weeks for recurrence of symptoms.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eosinophilic Esophagitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oral Viscous Budesonide (OVB)

Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.

Group Type ACTIVE_COMPARATOR

Oral Viscous Budesonide

Intervention Type DRUG

Oral Viscous Budesonide - 1 mg/4 mL, 4 mL of slurry twice daily

Placebo inhaler

Intervention Type DRUG

Placebo inhaler - 4 puffs twice daily

Active Fluticasone MDI

Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.

Group Type ACTIVE_COMPARATOR

Fluticasone MDI

Intervention Type DRUG

Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)

Placebo slurry

Intervention Type DRUG

Slurry of sucralose - 4 mL twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral Viscous Budesonide

Oral Viscous Budesonide - 1 mg/4 mL, 4 mL of slurry twice daily

Intervention Type DRUG

Fluticasone MDI

Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)

Intervention Type DRUG

Placebo slurry

Slurry of sucralose - 4 mL twice daily

Intervention Type DRUG

Placebo inhaler

Placebo inhaler - 4 puffs twice daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pulmicort Flovent Sucralose Placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age: 16 - 80 years
* Subject is having a clinically indicated endoscopy for suspicious EoE and has been on twice daily (BID) proton pump inhibitor (PPI) for at least 8 weeks OR New diagnosis of EoE as per consensus guidelines. Cases must have symptoms of dysphagia, persistent esophageal eosinophilia (≥ 15 eosinophils in at least one high-power field) after 8 weeks of treatment with a twice daily proton-pump inhibitor, and other competing causes of esophageal eosinophilia excluded.

Exclusion Criteria

* Medical instability that precludes safely performing upper endoscopy
* Ongoing or recent symptoms of intestinal bleeding (throwing up blood, passing blood in the stool)
* Concomitant eosinophilic gastroenteritis
* Esophageal narrowing or stricturing that will not allow a standard 9 mm upper endoscopy scope to pass
* Cancer in the esophagus, stomach, or intestine
* Previous esophageal surgery
* Esophageal varices (dilated blood vessels in the esophagus)
* Current use of blood thinners like Plavix or Coumadin that are not stopped prior to endoscopy procedures
* Any corticosteroid exposure within the 4 weeks prior to their baseline endoscopic exam. Exclusionary corticosteroid exposure is defined as any swallowed topical steroids for EoE or systemic steroids for any condition within the four weeks prior to the baseline endoscopy. Corticosteroids used for asthma or intranasal corticosteroids are not an exclusion and are allowable.
* Pregnancy
* Inability to read or understand English

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No