Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)
Primary Purpose
Eosinophilic Esophagitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
inhaled/swallowed budesonide
viscous/swallowed budesonide
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring eosinophilic esophagitis
Eligibility Criteria
Inclusion Criteria:
- New diagnosis of eosinophilic esophagitis (per 2007 consensus guidelines)
Exclusion Criteria:
- Age < 18
- Inability to read or understand English
- Pregnant or nursing women
- Previous allergic reactions to steroid medications
- Current use of systemic steroids
Sites / Locations
- University of North Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
inhaled/swallowed budesonide
viscous/swallowed budesonide
Arm Description
Outcomes
Primary Outcome Measures
Tissue Eosinophil Counts
Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment
Secondary Outcome Measures
Adrenal Insufficiency
Adrenal insufficiency as measured by a standard cortisol stimulation test (using 0.25 mg cosyntropin IV and baseline and 60 minute post-injection serum cortisol measurements) after treatment. A rise in serum cortisol concentration after to a peak of ≥18 mcg/dL was considered normal; a smaller rise than this was considered adrenal insufficiency.
Full Information
NCT ID
NCT00961233
First Posted
August 14, 2009
Last Updated
November 2, 2012
Sponsor
University of North Carolina, Chapel Hill
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT00961233
Brief Title
Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)
Official Title
Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE): Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
eosinophilic esophagitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
inhaled/swallowed budesonide
Arm Type
Experimental
Arm Title
viscous/swallowed budesonide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
inhaled/swallowed budesonide
Intervention Description
medication will be nebulized and then swallowed
Intervention Type
Drug
Intervention Name(s)
viscous/swallowed budesonide
Intervention Description
viscous suspension of budesonide will be swallowed
Primary Outcome Measure Information:
Title
Tissue Eosinophil Counts
Description
Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Adrenal Insufficiency
Description
Adrenal insufficiency as measured by a standard cortisol stimulation test (using 0.25 mg cosyntropin IV and baseline and 60 minute post-injection serum cortisol measurements) after treatment. A rise in serum cortisol concentration after to a peak of ≥18 mcg/dL was considered normal; a smaller rise than this was considered adrenal insufficiency.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
New diagnosis of eosinophilic esophagitis (per 2007 consensus guidelines)
Exclusion Criteria:
Age < 18
Inability to read or understand English
Pregnant or nursing women
Previous allergic reactions to steroid medications
Current use of systemic steroids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan S Dellon, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22561055
Citation
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.
Results Reference
derived
Learn more about this trial
Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)
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