Eosinophilic EsophagitisNCT00895817
Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis
A study testing Swallowed fluticasone and Esomeprazole in people with Eosinophilic Esophagitis, run by Walter Reed Army Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the clinical efficacy of proton pump inhibitors in comparison to aerosolized swallowed steroids for the treatment of eosinophilic esophagitis (EE). EE is an increasingly recognized disorder that has been associated with dysphagia and food impaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Swallowed fluticasone and Esomeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an established diagnosis of EE defined as > 20 eosinophils/HPF in the setting of dysphagia or food impaction.
- Males and females age > 18 years of age.
- Ability to undergo ambulatory pH monitoring.
- DEERS (Defense Enrollment Eligibility Reporting System) eligible.
- Willingness to take a one month holiday from a PPI or steroids if they have been prescribed this prior to enrollment.
- Willingness to participate and have additional biopsies taken during endoscopy and answer a questionnaire.
Who cannot join
- Patients < 18 years of age.
- Inability to give consent.
- Inability to undergo endoscopy or contraindications to endoscopy. Any medical condition or disorder (including drug allergies), which would preclude the use of conscious sedation or the ability to tolerate upper endoscopy.
- Contraindications to proton pump inhibitors or steroids.
- Inability to accurately fill out a short questionnaire.
- Pregnant females. A urine beta human chorionic gonadotropin (BHCG) prior to endoscopy will be offered to all female patients of child bearing potential (exceptions include post-menopausal, hysterectomy or bilateral tubal ligation). Positive BHCG results will prevent enrollment.
- Known coagulation abnormalities, thrombocytopenia and patients on coumadin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
Official title: Comparison of Aerosolized Swallowed Fluticasone to Esomeprazole for the Treatment of Eosinophilic Esophagitis
The purpose of this study is to assess the clinical efficacy of proton pump inhibitors in comparison to aerosolized swallowed steroids for the treatment of eosinophilic esophagitis (EE). EE is an increasingly recognized disorder that has been associated with dysphagia and food impaction. The presence of anatomical abnormalities in the esophagus such as longitudinal furrows, corrugated rings and a narrow caliber esophagus with friable mucosa are classic endoscopic findings. Diagnosis is established with the histologic finding of large numbers (> 15) of eosinophils per high power field. The underlying pathologic mechanism remains poorly understood but food allergies and aeroallergens have been implicated. It is well known that gastroesophageal reflux disease (GERD) may cause esophageal eosinophilia, but it is unclear whether a complex relationship exists between GERD and EE, as recent data suggests. Furthermore, a large number of patients with clinical presentations and endoscopic findings highly suggestive of EE which is confirmed on histology are responding favorably to proton pump inhibitors.
The aims of the study are to (1) compare the clinical efficacy of aerosolized swallowed Fluticasone to Esomeprazole for the treatment of eosinophilic esophagitis, (2) determine whether proton pump inhibitors are effective in the treatment of eosinophilic esophagitis, (3) determine the number of patients with eosinophilic esophagitis that have coexisting gastroesophageal reflux disease, and (4) correlate change in eosinophil count to improvement in symptoms before and after therapy.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Swallowed fluticasone, Esomeprazole
- Keywords
- Eosinophilic esophagitis, acid reflux
- Medical subject headings
- Eosinophilic Esophagitis, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowed fluticasoneDrug
440 µg twice daily for 8 weeks
EsomeprazoleDrug
40 mg once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Swallowed fluticasone | Active comparator | Not described Receives: Drug: Swallowed fluticasone |
| Esomeprazole | Active comparator | Not described Receives: Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Responded
Histologic resolution of esophageal eosinophilia. Response is defined as achieving < 7 eosinophils/high power field in both the proximal and distal esophagus.
Measured: 8 weeks
Secondary outcomes (2)
Symptom Score
Using a validated questionnaire, symptoms will be assessed at baseline and following therapy.
Measured: 8 weeks
Endoscopic Change
Following therapy, resolution of EE findings will be assessed.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startApr 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Fouad J. Moawad, Walter Reed Army Medical Center
- Investigators
- Fouad J Moawad, M.D., Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895817
- Sponsor's protocol ID
- 08-14045
- Status last verified
- Mar 2013
- First submitted
- 6 May 2009
- Last updated
- 12 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aerosolized Swallowed Fluticasone to Esomeprazole for the Treatment of Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT00895817
- Acronym / sponsor ID
- 08-14045
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic esophagitis, acid reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- Apr 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 May 2009 (estimated)
- Results
- Posted 12 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the clinical efficacy of proton pump inhibitors in comparison to aerosolized swallowed steroids for the treatment of eosinophilic esophagitis (EE). EE is an increasingly recognized disorder that has been associated with dysphagia and food impaction. The presence of anatomical abnormalities in the esophagus such as longitudinal furrows, corrugated rings and a narrow caliber esophagus with friable mucosa are classic endoscopic findings. Diagnosis is established with the histologic finding of large numbers (> 15) of eosinophils per high power field. The underlying pathologic mechanism remains poorly understood but food allergies and aeroallergens have been implicated. It is well known that gastroesophageal reflux disease (GERD) may cause esophageal eosinophilia, but it is unclear whether a complex relationship exists between GERD and EE, as recent data suggests. Furthermore, a large number of patients with clinical presentations and endoscopic findings highly suggestive of EE which is confirmed on histology are responding favorably to proton pump inhibitors.
The aims of the study are to (1) compare the clinical efficacy of aerosolized swallowed Fluticasone to Esomeprazole for the treatment of eosinophilic esophagitis, (2) determine whether proton pump inhibitors are effective in the treatment of eosinophilic esophagitis, (3) determine the number of patients with eosinophilic esophagitis that have coexisting gastroesophageal reflux disease, and (4) correlate change in eosinophil count to improvement in symptoms before and after therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swallowed fluticasone | Active comparator | Drug: Swallowed fluticasone |
| Esomeprazole | Active comparator | Drug: Esomeprazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with an established diagnosis of EE defined as > 20 eosinophils/HPF in the setting of dysphagia or food impaction.
- Males and females age > 18 years of age.
- Ability to undergo ambulatory pH monitoring.
- DEERS (Defense Enrollment Eligibility Reporting System) eligible.
- Willingness to take a one month holiday from a PPI or steroids if they have been prescribed this prior to enrollment.
Key exclusion criteria (7 listed)
- Patients < 18 years of age.
- Inability to give consent.
- Inability to undergo endoscopy or contraindications to endoscopy. Any medical condition or disorder (including drug allergies), which would preclude the use of conscious sedation or the ability to tolerate upper endoscopy.
- Contraindications to proton pump inhibitors or steroids.
- Inability to accurately fill out a short questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swallowed fluticasone440 µg twice daily for 8 weeks | Drug | Swallowed fluticasone |
| Esomeprazole40 mg once daily for 8 weeks | Drug | Esomeprazole |
Primary outcome
Number of Participants Who Responded
Time frame: 8 weeks
Histologic resolution of esophageal eosinophilia. Response is defined as achieving < 7 eosinophils/high power field in both the proximal and distal esophagus.
2 secondary outcomes
Symptom Score
Time frame: 8 weeks
Endoscopic Change
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Eosinophilic Esophagitis
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Natural History and Genetics of Food Allergy and Related Conditions
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A Study in Adult Participants With EoE to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 20 mg Up to 24 Weeks
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A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fouad J Moawad, M.D. principal investigator
Walter Reed Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swallowed fluticasone and Esomeprazole in people with Eosinophilic Esophagitis, run by Walter Reed Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Responded (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2013; AzTrials last refreshed its copy on 26 Oct 2026.