Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)
1 other identifier
interventional
25
1 country
1
Brief Summary
The purpose of this study is to conduct a clinical trial of two formulations of budesonide (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if medication contact time and distribution in the esophagus relates to treatment response. The investigators will also determine if there is systemic absorption of these topical steroids. The investigators hypothesize that tissue and symptom response will correlate with esophageal medication contact time and distribution, and that significant systemic absorption will not be seen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
November 5, 2012
CompletedNovember 6, 2012
November 1, 2012
1.8 years
August 14, 2009
September 4, 2012
November 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tissue Eosinophil Counts
Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment
8 weeks
Secondary Outcomes (1)
Adrenal Insufficiency
8 weeks
Study Arms (2)
inhaled/swallowed budesonide
EXPERIMENTALviscous/swallowed budesonide
ACTIVE COMPARATORInterventions
medication will be nebulized and then swallowed
viscous suspension of budesonide will be swallowed
Eligibility Criteria
You may qualify if:
- New diagnosis of eosinophilic esophagitis (per 2007 consensus guidelines)
You may not qualify if:
- Age \< 18
- Inability to read or understand English
- Pregnant or nursing women
- Previous allergic reactions to steroid medications
- Current use of systemic steroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hilllead
- AstraZenecacollaborator
Study Sites (1)
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Related Publications (1)
Dellon ES, Sheikh A, Speck O, Woodward K, Whitlow AB, Hores JM, Ivanovic M, Chau A, Woosley JT, Madanick RD, Orlando RC, Shaheen NJ. Viscous topical is more effective than nebulized steroid therapy for patients with eosinophilic esophagitis. Gastroenterology. 2012 Aug;143(2):321-4.e1. doi: 10.1053/j.gastro.2012.04.049. Epub 2012 May 3.
PMID: 22561055DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Evan S. Dellon, MD MPH
- Organization
- University of North Carolina School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Evan S Dellon, MD, MPH
University of North Carolina, Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MPH
Study Record Dates
First Submitted
August 14, 2009
First Posted
August 18, 2009
Study Start
October 1, 2009
Primary Completion
August 1, 2011
Study Completion
November 1, 2011
Last Updated
November 6, 2012
Results First Posted
November 5, 2012
Record last verified: 2012-11