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NCT02019758 · ClinicalTrials.gov registry record · Phase 4
Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 129
- Enrollment target
NCT02019758: Completed Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT02019758 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 129 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02019758, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 129 participants
- Enrollment target
Study Summary
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
Primary Outcome
To determine whether viscous budesonide is more effective than fluticasone MDI for improving post-treatment maximum esophageal eosinophil counts (measured in eosinophils per high powered field (eos/hpf)) in patients with eosinophilic esophagitis (EoE). The mean post-treatment maximum eosinophil count will be compared between the OVB and MDI groups using a two-sample t-test.
Interventions
- DRUG Oral Viscous Budesonide
- DRUG Fluticasone MDI
- DRUG Placebo slurry
- DRUG Placebo inhaler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2015-01-01 |
| Est. Completion | 2019-04 |
| Phase | Phase 4 |
What the finished NCT02019758 record still lists
NCT02019758 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 4 interventions - of which Oral Viscous Budesonide is the first listed.
NCT02019758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02019758 about?
NCT02019758 is a clinical study titled "Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis". 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. Partic...
What is the current status of trial NCT02019758?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 129 participants. The study started on 2015-01-01. Estimated completion is 2019-04.
What interventions are being tested in trial NCT02019758?
The interventions under investigation include: Oral Viscous Budesonide (DRUG), Fluticasone MDI (DRUG), Placebo slurry (DRUG), Placebo inhaler (DRUG).
Who is sponsoring clinical trial NCT02019758?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02019758's enrollment target sits among peer trials
129 631st of 2000 higher than 1,367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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