Eosinophilic Esophagitis
Conditions
Keywords
eosinophilic esophagitis
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.
Interventions
DRUGinhaled/swallowed budesonide
medication will be nebulized and then swallowed
DRUGviscous/swallowed budesonide
viscous suspension of budesonide will be swallowed
Sponsors
AstraZeneca
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissue Eosinophil Counts | 8 weeks | Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adrenal Insufficiency | 8 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inhaled/Swallowed Budesonide | 13 |
| Viscous/Swallowed Budesonide | 12 |
| Total | 25 |
Baseline characteristics
| Characteristic | Inhaled/Swallowed Budesonide | Viscous/Swallowed Budesonide | Total |
|---|---|---|---|
| Age Continuous | 34.9 years STANDARD_DEVIATION 7.3 | 34.4 years STANDARD_DEVIATION 7.5 | 34.7 years STANDARD_DEVIATION 7.4 |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Tissue Eosinophil Counts
Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled/Swallowed Budesonide | Tissue Eosinophil Counts | 89 # of eosinophils per high-power field | Standard Deviation 94 |
| Viscous/Swallowed Budesonide | Tissue Eosinophil Counts | 11 # of eosinophils per high-power field | Standard Deviation 23 |
Secondary
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.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inhaled/Swallowed Budesonide | Adrenal Insufficiency | 0 participants |
| Viscous/Swallowed Budesonide | Adrenal Insufficiency | 0 participants |