A Phase 2/3 interventional study of Esomeprazole and Budesonide in Eosinophilic Esophagitis, Gastroesophageal Reflux Disease and EE, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-01-14.
Sponsored by Mayo Clinic · Phase 2/3, Interventional, and Treatment
The primary aim of this study was to determine the proportion of patients with esophageal eosinophilic infiltration that have objective (measurable) evidence of gastroesophageal reflux disease (GERD).
This study was also done to see if patients that have eosinophilic esophagitis (EE) and GERD would receive relief from taking the medication Nexium or a steroid called Pulmicort.
The study also evaluated the accuracy of pH monitoring (acid exposure) within the esophagus as a predictor of endoscopic, histological and symptomatic response in patients with EE.
Hypotheses:
Participants were randomized based on results of a 24 hour pH study, which determined the average percent time the distal esophagus was exposed to a pH of less than than 4. Subjects with a positive pH result were randomized to esomeprazole or randomized to budesonide, if there was a negative pH result. Studies were interpreted by a single gastroenterologist experienced in reading esophageal pH studies. The percent time the pH monitor detected a pH less than 4 was recorded and an esophageal pH of less than 4 for 4% or greater of the study time was considered abnormal. Note: pH is a measure of acidity or alkalinity (lower numbers are more acid, higher numbers are more alkaline).
Those subjects with GERD (positive pH result) received gastric acid-suppressing medication (esomeprazole 40 mg, twice daily) for 6 weeks. Subjects who did not have GERD (negative pH result) were treated with a corticosteroid designed to coat the esophagus (budesonide suspension 1 mg twice daily) for six weeks. Response to treatment was assessed by esophageal histology and symptoms.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 51 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
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Exclusion Criteria:
Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study (GERD)
Drug: Esomeprazole
Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose \[Splenda-registered trademark\]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
Drug: Budesonide
Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks
Also known as: Nexium
Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose \[Splenda-registered trademark\]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
Also known as: Pulmicort
Histological Response to Treatment
Subjects with Esophageal eosinophilia experiencing a histological response to treatment. Subjects were considered to have histological response to treatment if both sets of biopsies (from the distal and mid-esophagus) had, on average, less than 5 eosinophils per high power field (eos/hpf) at the 6-month biopsies.
Time frame: Baseline, 6 months
Symptomatic Response to Treatment
Subjects with Esophageal eosinophilia experiencing a response in their dysphagia symptoms to treatment. Symptomatic improvement in symptoms was defined as a score of at least two levels lower than the baseline dysphagia symptom question on the Mayo Dysphagia Questionnaire-30 days (MDQ-30). Dysphagia symptoms were determined based on the MDQ-30 question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study.
Time frame: Baseline, 6 months
Change in Dysphagia Symptoms in Subjects With Histological Response to Treatment
Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Symptomatic improvement was defined as only an improvement of 2 levels on this question.
Time frame: Baseline, 6 months
Change in Dysphagia Symptoms in Subjects With Non-significant Histological Response to Treatment
Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study.
Time frame: Baseline, 6 months
Participants With Presence of Esophageal Rings/Furrows at Six Month Endoscopy
Multiple concentric rings or furrows of the esophagus is an endoscopic finding traditionally ascribed to eosinophilic esophagitis.
Time frame: Baseline, 6 months
Participants With Presence of Erosive Esophagitis at Six Month Endoscopy
Time frame: Baseline, 6 months
Subjects with a clinical diagnosis of Eosinophilic Esophagitis (EE) were recruited by mail using a Mayo Clinic proprietary database and also by direct contact in the Mayo Clinic Esophageal Diseases speciality clinic in Rochester, MN. Subjects were enrolled from 3/2009 to 8/2010.
| Milestone | Esomeprazole | Budesonide |
|---|---|---|
| Started | 19 | 32 |
| Completed | 18 | 28 |
| Not completed | 1 | 4 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Study medication non-compliance | 0 | 2 |
| Withdrew: Incorrectly assigned to opposite arm | 1 | 0 |
Subjects with Esophageal eosinophilia experiencing a histological response to treatment. Subjects were considered to have histological response to treatment if both sets of biopsies (from the distal and mid-esophagus) had, on average, less than 5 eosinophils per high power field (eos/hpf) at the 6-month biopsies.
| Participants | Esomeprazole | Budesonide |
|---|---|---|
| Subjects with histological response | 11 | 16 |
| Subjects with nonsignificant histological response | 7 | 12 |
Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Symptomatic improvement was defined as only an improvement of 2 levels on this question.
| Participants | Esomeprazole | Budesonide |
|---|---|---|
| Dysphagia symptoms improved | 5 | 11 |
| Dysphagia symptoms did not improve | 6 | 5 |
Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study.
| Participants | Esomeprazole | Budesonide |
|---|---|---|
| Dysphagia symptoms responded to treatment | 6 | 4 |
| Dysphagia symptoms did not respond | 1 | 8 |
Multiple concentric rings or furrows of the esophagus is an endoscopic finding traditionally ascribed to eosinophilic esophagitis.
| participants | Esomeprazole | Budesonide |
|---|---|---|
| Participants With Presence of Esophageal Rings/Furrows at Six Month Endoscopy | 11 | 17 |
| participants | Esomeprazole | Budesonide |
|---|---|---|
| Participants With Presence of Erosive Esophagitis at Six Month Endoscopy | 1 | 8 |
Subjects with Esophageal eosinophilia experiencing a response in their dysphagia symptoms to treatment. Symptomatic improvement in symptoms was defined as a score of at least two levels lower than the baseline dysphagia symptom question on the Mayo Dysphagia Questionnaire-30 days (MDQ-30). Dysphagia symptoms were determined based on the MDQ-30 question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study.
| Participants | Esomeprazole | Budesonide |
|---|---|---|
| Subjects with response in dysphagia symptoms | 11 | 15 |
| Subjects with no response in dysphagia symptoms | 7 | 13 |
Collected over Baseline to 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Esomeprazole | — | 0/18 (0%) | 1/18 (5.6%) |
| Budesonide | — | 0/28 (0%) | 1/28 (3.6%) |
| Event | Esomeprazole | Budesonide |
|---|---|---|
| HivesImmune system disorders | 1/18 | 1/28 |
| Age, Continuous(years) | Esomeprazole | Budesonide | Total |
|---|---|---|---|
| Mean | 47.5 ± 14.9 | 33.7 ± 10.4 | 39 ± 13.9 |
| Sex: Female, Male(Participants) | Esomeprazole | Budesonide | Total |
|---|---|---|---|
| Female | 7 | 13 | 20 |
| Male | 12 | 19 | 31 |
| Region of Enrollment(participants) | Esomeprazole | Budesonide | Total |
|---|---|---|---|
| United States | 19 | 32 | 51 |
| Mean number of eosinophils per high powered field in esophagus(eos/hpf) | Esomeprazole | Budesonide | Total |
|---|---|---|---|
| Mean | 35.6 ± 24.7 | 46.7 ± 26.5 | 41.2 ± 27.7 |
| Endoscopic evidence of GERD(Participants) | Esomeprazole | Budesonide | Total |
|---|---|---|---|
| Multiple rings (felinization or corrugations) | 14 | 18 | 32 |
| Hiatal hernia | 15 | 10 | 25 |
| Erosive esophagitis | 7 | 2 | 9 |
| Number of participants with frequent GERD/dysphagia symptoms(participants) | Esomeprazole | Budesonide | Total |
|---|---|---|---|
| Frequent symptoms | 15 | 0 | 15 |
| No or infrequent symptoms | 3 | 17 | 20 |
| No symptoms | 0 | 15 | 15 |
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