EsophagitisPhase 2NCT00123656
Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
A Phase 2 study testing esomeprazole and fluticasone in people with Esophagitis, run by University of Utah at 1 site in United States.
Trial summary
Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be related to both allergies and acid reflux. There have been reports that both swallowed, aerosolized steroids and proton pump inhibitors have been effective treatments. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophagitis
- What is being tested?
- esomeprazole and fluticasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 with EE, defined as: a) dysphagia, food impaction or other upper gastrointestinal symptoms (chest pain, heartburn, regurgitation); b) multiple esophageal rings or furrows; c) the presence of >20 eosinophils/high power field in the squamous epithelium or deeper tissues of the esophagus
- Ability to undergo esophageal manometry and ambulatory pH monitoring
- No history of bleeding diathesis, significant cardiopulmonary disease, or other contraindication to upper endoscopy
- Those who have had a one month holiday from either esomeprazole therapy or fluticasone if they have been prescribed this prior to enrollment
Who cannot join
- Contraindication to proton pump inhibitors or swallowed fluticasone
- Need for immediate esophageal dilation at enrollment due to food impaction at the discretion of the performing endoscopist
- Inability to pass endoscope
- Pregnancy
- Incarceration
- Inability to provide informed consent
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- History of esophago-gastric surgery or prior history of abdominal surgery with subsequent strictures or symptoms of obstruction such as abdominal pain and bloating
- Presence of other esophageal pathology that could account for patients' symptoms as determined by histological interpretation by the pathologist
- History of esophageal spasm resulting in trouble swallowing foods larger than 1 cm in diameter
Trial locations and contacts
1 site in 1 country.
About this study
Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be related to both allergies and acid reflux. There have been reports that both swallowed, aerosolized steroids and proton pump inhibitors have been effective treatments. The researchers propose to directly compare the efficacy of aerosolized fluticasone to esomeprazole in the treatment of eosinophilic esophagitis. The hypothesis is that aerosolized fluticasone (Flovent) will be more effective in relieving symptoms of EE than esomeprazole (Nexium) treatment. Patients will undergo endoscopy, pH monitoring and manometry for diagnosis. Following diagnosis of EE by pathology (biopsy of esophagus), patients will be randomized to esomeprazole or swallowed fluticasone for 8 weeks. At the end of 8 weeks, subjects will be asked to repeat upper endoscopy with biopsies. Three questionnaires (dysphagia, gastroesophageal reflux disease [GERD], and allergy) will be completed by the patient at the first endoscopy and at the end endoscopy. The primary objective is to measure change in eosinophil infiltration of the esophagus in response to treatment of allergy (swallowed fluticasone) versus treatment for reflux (esomeprazole) in EE patients.
Read the detailed description
This is a randomized, non-blinded, multicenter treatment trial to demonstrate and compare the efficacy of esomeprazole and fluticasone in the treatment of eosinophilic esophagitis.
Following the initial diagnostic EGD with four quadrant biopsy, serum eosinophil count and serum IgE levels will be measured. Patients will undergo 24 hour pH study to determine the incidence of reflux in this population. Clinical assessment will be performed with validated questionnaires quantifying dysphagia, GERD, and allergy/atopy. Patients will be randomized to 8 weeks of either esomeprazole versus swallowed aerosolized fluticasone. After 8 weeks of therapy, upper endoscopy will again be performed. Eosinophils per high power field will be quantified, and biopsies will be stained for major basic protein. Dysphagia, GERD, and allergy/atopy questionnaires will be repeated, as will serum eosinophil counts and IgE measurements.
- Conditions
- Esophagitis
- Being tested
- esomeprazole, fluticasone
- Keywords
- Eosinophilic esophagitis, esomeprazole, fluticasone
- Medical subject headings
- Esophagitis, Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazoleDrug
Also called Nexium
esomeprazole dosed qam for 8 weeks
fluticasoneDrug
Also called Flovent
fluticasone dosed 220 mcg 2 puffs swallowed BID for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | fluticasone Receives: Drug: fluticasone |
| 2 | Active comparator | esomeprazole Receives: Drug: esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure change in eosinophil infiltration and degranulation at 8 weeks in response to treatment of allergy versus treatment for GER in EE patients
Measured: 8 weeks
Secondary outcomes (1)
To assess change in dysphagia score, GERD symptoms, allergy/atopy at 8 weeks using validated questionnaires
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 posted25 Jul 2005 (estimated)
- Study startAug 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagitisStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Investigators
- John C. Fang, M.D., Principal investigator, University of Utah HSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123656
- Sponsor's protocol ID
- 12790
- Status last verified
- Jan 2008
- First submitted
- 21 Jul 2005
- Last updated
- 16 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT00123656
- Acronym / sponsor ID
- 12790
- Conditions
- Esophagitis
- Keywords
- Eosinophilic esophagitis, esomeprazole, fluticasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Study start
- Aug 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 25 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be related to both allergies and acid reflux. There have been reports that both swallowed, aerosolized steroids and proton pump inhibitors have been effective treatments. The researchers propose to directly compare the efficacy of aerosolized fluticasone to esomeprazole in the treatment of eosinophilic esophagitis. The hypothesis is that aerosolized fluticasone (Flovent) will be more effective in relieving symptoms of EE than esomeprazole (Nexium) treatment. Patients will undergo endoscopy, pH monitoring and manometry for diagnosis. Following diagnosis of EE by pathology (biopsy of esophagus), patients will be randomized to esomeprazole or swallowed fluticasone for 8 weeks. At the end of 8 weeks, subjects will be asked to repeat upper endoscopy with biopsies. Three questionnaires (dysphagia, gastroesophageal reflux disease [GERD], and allergy) will be completed by the patient at the first endoscopy and at the end endoscopy. The primary objective is to measure change in eosinophil infiltration of the esophagus in response to treatment of allergy (swallowed fluticasone) versus treatment for reflux (esomeprazole) in EE patients.
Detailed description
This is a randomized, non-blinded, multicenter treatment trial to demonstrate and compare the efficacy of esomeprazole and fluticasone in the treatment of eosinophilic esophagitis.
Following the initial diagnostic EGD with four quadrant biopsy, serum eosinophil count and serum IgE levels will be measured. Patients will undergo 24 hour pH study to determine the incidence of reflux in this population. Clinical assessment will be performed with validated questionnaires quantifying dysphagia, GERD, and allergy/atopy. Patients will be randomized to 8 weeks of either esomeprazole versus swallowed aerosolized fluticasone. After 8 weeks of therapy, upper endoscopy will again be performed. Eosinophils per high power field will be quantified, and biopsies will be stained for major basic protein. Dysphagia, GERD, and allergy/atopy questionnaires will be repeated, as will serum eosinophil counts and IgE measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: fluticasonefluticasone |
| 2 | Active comparator | Drug: esomeprazoleesomeprazole |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-80 with EE, defined as: a) dysphagia, food impaction or other upper gastrointestinal symptoms (chest pain, heartburn, regurgitation); b) multiple esophageal rings or furrows; c) the presence of >20 eosinophils/high power field in the squamous epithelium or deeper tissues of the esophagus
- Ability to undergo esophageal manometry and ambulatory pH monitoring
- No history of bleeding diathesis, significant cardiopulmonary disease, or other contraindication to upper endoscopy
- Those who have had a one month holiday from either esomeprazole therapy or fluticasone if they have been prescribed this prior to enrollment
Key exclusion criteria (9 listed)
- Contraindication to proton pump inhibitors or swallowed fluticasone
- Need for immediate esophageal dilation at enrollment due to food impaction at the discretion of the performing endoscopist
- Inability to pass endoscope
- Pregnancy
- Incarceration
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 |
|---|---|---|
| esomeprazoleAlso: Nexiumesomeprazole dosed qam for 8 weeks | Drug | 2 |
| fluticasoneAlso: Floventfluticasone dosed 220 mcg 2 puffs swallowed BID for 8 weeks | Drug | 1 |
Primary outcome
To measure change in eosinophil infiltration and degranulation at 8 weeks in response to treatment of allergy versus treatment for GER in EE patients
Time frame: 8 weeks
1 secondary outcome
To assess change in dysphagia score, GERD symptoms, allergy/atopy at 8 weeks using validated questionnaires
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2008.
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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.
John C. Fang, M.D. principal investigator
University of Utah HSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing esomeprazole and fluticasone in people with Esophagitis, run by University of Utah 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 4 inclusion and 9 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 16 Jan 2008. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To measure change in eosinophil infiltration and degranulation at 8 weeks in response to treatment of allergy versus treatment for GER in EE patients (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 16 Jan 2008.