Eosinophilic Esophagitis
Conditions
Keywords
Eosinophils, Esophagitis, Microscopy
Brief summary
This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.
Interventions
DRUGBudesonide plus Prevacid
Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
DRUGplacebo plus Prevacid
Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
Sponsors
Meritage Pharma, Inc.
Ranjan Dohil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal biopsy * Ages 1 yrs and older * Ability to continue the same diet that the patient was on at the time of EGD with biopsy
Exclusion criteria
* Adverse reaction or allergy to budesonide * Pregnancy * Chronic diseases requiring immunomodulatory therapy * Use of swallowed topical corticosteroids for EE within the past 3 months * Use of systemic steroids 2 months prior to study entry * Upper gastrointestinal bleed within 4 months of study entry * Chronic use of medications that predispose to upper gastrointestinal bleeding including non-steroidal anti-inflammatory medications or anticoagulants * Evidence of adrenal suppression prior to study entry * Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis * Recent changes in asthma or allergic rhinitis therapy for 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improvement of Espohageal Eosinophilia | 3 Months | Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper Gastrointestinal Endoscopy Score | Baseline and 3 Months | Endoscopy scoring tool took into account the following categories: Mucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/tissue-paper mucosa Histology scoring tools Epithelial histology score Peak eosinophil count Each category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease. |
| Symptom Score | Baseline and 3 Months | Total score was based on the following symptoms: Heartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding Each symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oral Viscous Budesonide Plus Prevacid Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months. | 21 |
| Placebo Plus Prevacid placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months. | 11 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 6 | 2 |
Baseline characteristics
| Characteristic | Oral Viscous Budesonide Plus Prevacid | Placebo Plus Prevacid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 21 Participants | 11 Participants | 32 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 2 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 0 Participants | 6 Participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 17 Participants | 10 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 11 |
| other Total, other adverse events | 3 / 21 | 5 / 11 |
| serious Total, serious adverse events | 0 / 21 | 0 / 11 |
Outcome results
Primary
Number of Participants With Improvement of Espohageal Eosinophilia
Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.
Time frame: 3 Months
Population: 6 subjects withdrew from the oral viscous budesonide plus Prevacid group and 2 withdrew from the placebo plus Prevacid group, and so they were not included in the data analsyis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Viscous Budesonide Plus Prevacid | Number of Participants With Improvement of Espohageal Eosinophilia | 13 Participants |
| Placebo Plus Prevacid | Number of Participants With Improvement of Espohageal Eosinophilia | 0 Participants |
Secondary
Symptom Score
Total score was based on the following symptoms: Heartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding Each symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms.
Time frame: Baseline and 3 Months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oral Viscous Budesonide Plus Prevacid | Symptom Score | Baseline | 3.5 units on a scale |
| Oral Viscous Budesonide Plus Prevacid | Symptom Score | 3 months | 1.2 units on a scale |
| Placebo Plus Prevacid | Symptom Score | Baseline | 2.7 units on a scale |
| Placebo Plus Prevacid | Symptom Score | 3 months | 1.8 units on a scale |
Secondary
Upper Gastrointestinal Endoscopy Score
Endoscopy scoring tool took into account the following categories: Mucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/tissue-paper mucosa Histology scoring tools Epithelial histology score Peak eosinophil count Each category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease.
Time frame: Baseline and 3 Months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oral Viscous Budesonide Plus Prevacid | Upper Gastrointestinal Endoscopy Score | Baseline | 4.6 units on a scale |
| Oral Viscous Budesonide Plus Prevacid | Upper Gastrointestinal Endoscopy Score | 3 months | 1.5 units on a scale |
| Placebo Plus Prevacid | Upper Gastrointestinal Endoscopy Score | 3 months | 5.4 units on a scale |
| Placebo Plus Prevacid | Upper Gastrointestinal Endoscopy Score | Baseline | 7.8 units on a scale |