A Randomized Double Blind Placebo Controlled Study of the Effect of Swallowed Beclomethasone Dipropionate on Inflammatory Markers in Adult Patients With Eosinophilic Esophagitis

Completed · Phase 1 · Has a placebo group

Conditions studied: Eosinophilic Esophagitis

In brief

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.

Key facts

Study ID

NCT01016223

Run by

Penn State University

People needed

20

Starts

2010-03-01

Expected to finish

2012-10-01

Last updated by the study team

2012-11-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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