Eosinophilic EsophagitisPhase 1NCT01016223
A Randomized Double Blind Placebo Controlled Study of the Effect of Swallowed Beclomethasone Dipropionate on Inflammatory Markers in Adult Patients With Eosinophilic Esophagitis
A Phase 1 study testing Beclomethasone dipropionate in people with Eosinophilic Esophagitis, run by Penn State University at 1 site in United States.
Trial summary
The investigators hypothesize that swallowed beclomethasone leads not only to improvement of symptoms and decreased number of eosinophils in esophageal mucosa, but also to a decrease in other markers of tissue inflammation like mast cells, CD4+ T lymphocytes, IL4, IL-5, IL13, GM-CSF and TGF-beta as well as serum… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Beclomethasone dipropionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Oct 2012
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 years of age or older with biopsy proven diagnosis of EoE.
- Subjects who are able and willing to provide consent for repeat EGDs with esophageal biopsies, and blood work as per study protocol.
Who cannot join
- Subjects with suspected or proven inflammatory bowel disease, malignancy, and collagen-vascular disease.
- Subjects who have used oral, inhaled or swallowed corticosteroids in the past 3 months.
- Subjects who are pregnant or breastfeeding
- Subjects who are not able to swallow beclomethasone or are intolerant to the medication.
- Subjects with history of ischemic heart disease, diabetes and dyslipidemia unless they have been stable in the last six months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
The investigators hypothesize that swallowed beclomethasone leads not only to improvement of symptoms and decreased number of eosinophils in esophageal mucosa, but also to a decrease in other markers of tissue inflammation like mast cells, CD4+ T lymphocytes, IL4, IL-5, IL13, GM-CSF and TGF-beta as well as serum ultra-sensitive C-Reactive Protein (CRP). The investigators aim to characterize the response of esophageal inflammation to swallowed topical glucocorticoids, and identify biomarkers to assess response to treatment.
This research will elucidate the effect of treatment with beclomethasone on various inflammatory markers in EoE, which is currently not well-understood. This work will explore the pathophysiology of EoE, and has the potential to find a non-invasive biomarker such as high-sensitivity CRP that can be used to monitor the response to treatment.
Read the detailed description
EoE is an increasingly recognized clinicopathological diagnosis, characterized by a marked accumulation of eosinophils in the esophageal mucosa.The presence of eosinophils and association of the disease with food allergy and allergic rhinitis suggests an atopic disease. Allergic diseases are associated with T-helper 2 lymphocytes (TH2) predominant cytokines such as interleukins 4, 5, 13 (IL4, IL5, IL13), which are known to induce IgE synthesis and promote eosinophilic infiltration. Granulocyte-Monocyte Colony Stimulating Factor (GM-CSF) and Transforming Growth Factor (TGF) - beta are cytokines which are associated with many eosinophilic disorders. Swallowed steroid is a conventional treatment that has been shown to improve symptoms and decrease number of eosinophils in the esophagus in patients with EoE. However, no studies have investigated the effect of swallowed steroid on markers of TH2 inflammation in adult patients with EoE.Currently repeated endoscopic biopsy of esophagus is the only tool to monitor response to treatment. Serum ultra- sensitive CRP is a non-invasive marker of inflammation in cardiovascular and gastrointestinal disorders. This study proposes to investigate the correlation of disease activity with this potential marker of inflammation in adult patients with EoE which has not been previously studied.
Specific Aim #1: To measure the baseline level of a proposed panel of inflammatory markers: serum ultra-sensitive CRP and peripheral eosinophils, as well as tissue eosinophils, mast cells, CD4 cells, IL-4, IL-5, IL-13, GM-CSF and TGF-beta in the esophagus in adult patients with eosinophilic esophagitis.
Specific Aim #2: To determine the impact of 8 week course of treatment with swallowed beclomethasone on the levels of the inflammatory markers measured in Specific Aim #1.
Specific Aim #3: To determine the correlation between the levels of the proposed panel of inflammatory markers and symptoms of EoE before and after 8 weeks of treatment with swallowed beclomethasone.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Beclomethasone dipropionate, placebo
- Keywords
- Eosinophilic esophagitis, Beclomethasone, Ultrasensitive CRP
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclomethasone dipropionateDrug
Beclomethasone dipropionate 80 mcg two puffs twice daily for 8 weeks
placeboDrug
Matched placebo swallowed two puffs twice daily
| Study group | Role | What they receive |
|---|---|---|
| Beclomethasone dipropionate inhaler | Active comparator | Not described Receives: Drug: Beclomethasone dipropionate |
| Matched inhaler | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom improvement
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startMar 2010
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gisoo Ghaffari, Penn State University
- Investigators
- GISOO GHAFFARI, MD, Principal investigator, Penn State College of Medicine Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016223
- Sponsor's protocol ID
- 32508
- Status last verified
- Nov 2012
- First submitted
- 18 Nov 2009
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Placebo Controlled Study of the Effect of Swallowed Beclomethasone Dipropionate on Inflammatory Markers in Adult Patients With Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT01016223
- Acronym / sponsor ID
- 32508
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic esophagitis, Beclomethasone, Ultrasensitive CRP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 19 Nov 2009 (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.
The investigators hypothesize that swallowed beclomethasone leads not only to improvement of symptoms and decreased number of eosinophils in esophageal mucosa, but also to a decrease in other markers of tissue inflammation like mast cells, CD4+ T lymphocytes, IL4, IL-5, IL13, GM-CSF and TGF-beta as well as serum ultra-sensitive C-Reactive Protein (CRP). The investigators aim to characterize the response of esophageal inflammation to swallowed topical glucocorticoids, and identify biomarkers to assess response to treatment.
This research will elucidate the effect of treatment with beclomethasone on various inflammatory markers in EoE, which is currently not well-understood. This work will explore the pathophysiology of EoE, and has the potential to find a non-invasive biomarker such as high-sensitivity CRP that can be used to monitor the response to treatment.
Detailed description
EoE is an increasingly recognized clinicopathological diagnosis, characterized by a marked accumulation of eosinophils in the esophageal mucosa.The presence of eosinophils and association of the disease with food allergy and allergic rhinitis suggests an atopic disease. Allergic diseases are associated with T-helper 2 lymphocytes (TH2) predominant cytokines such as interleukins 4, 5, 13 (IL4, IL5, IL13), which are known to induce IgE synthesis and promote eosinophilic infiltration. Granulocyte-Monocyte Colony Stimulating Factor (GM-CSF) and Transforming Growth Factor (TGF) - beta are cytokines which are associated with many eosinophilic disorders. Swallowed steroid is a conventional treatment that has been shown to improve symptoms and decrease number of eosinophils in the esophagus in patients with EoE. However, no studies have investigated the effect of swallowed steroid on markers of TH2 inflammation in adult patients with EoE.Currently repeated endoscopic biopsy of esophagus is the only tool to monitor response to treatment. Serum ultra- sensitive CRP is a non-invasive marker of inflammation in cardiovascular and gastrointestinal disorders. This study proposes to investigate the correlation of disease activity with this potential marker of inflammation in adult patients with EoE which has not been previously studied.
Specific Aim #1: To measure the baseline level of a proposed panel of inflammatory markers: serum ultra-sensitive CRP and peripheral eosinophils, as well as tissue eosinophils, mast cells, CD4 cells, IL-4, IL-5, IL-13, GM-CSF and TGF-beta in the esophagus in adult patients with eosinophilic esophagitis.
Specific Aim #2: To determine the impact of 8 week course of treatment with swallowed beclomethasone on the levels of the inflammatory markers measured in Specific Aim #1.
Specific Aim #3: To determine the correlation between the levels of the proposed panel of inflammatory markers and symptoms of EoE before and after 8 weeks of treatment with swallowed beclomethasone.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beclomethasone dipropionate inhaler | Active comparator | Drug: Beclomethasone dipropionate |
| Matched inhaler | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subjects 18 years of age or older with biopsy proven diagnosis of EoE.
- Subjects who are able and willing to provide consent for repeat EGDs with esophageal biopsies, and blood work as per study protocol.
Key exclusion criteria (5 listed)
- Subjects with suspected or proven inflammatory bowel disease, malignancy, and collagen-vascular disease.
- Subjects who have used oral, inhaled or swallowed corticosteroids in the past 3 months.
- Subjects who are pregnant or breastfeeding
- Subjects who are not able to swallow beclomethasone or are intolerant to the medication.
- Subjects with history of ischemic heart disease, diabetes and dyslipidemia unless they have been stable in the last six months.
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 |
|---|---|---|
| Beclomethasone dipropionateBeclomethasone dipropionate 80 mcg two puffs twice daily for 8 weeks | Drug | Beclomethasone dipropionate inhaler |
| placeboMatched placebo swallowed two puffs twice daily | Drug | Matched inhaler |
Primary outcome
Symptom improvement
Time frame: 5 months
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 30 Nov 2012.
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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.
GISOO GHAFFARI, MD principal investigator
Penn State College of Medicine Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Beclomethasone dipropionate in people with Eosinophilic Esophagitis, run by Penn State University 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 2 inclusion and 5 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 30 Nov 2012. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Symptom improvement (time frame: 5 months). 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 30 Nov 2012; AzTrials last refreshed its copy on 29 Oct 2026.