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

NCT01016223 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-11-30

No results posted yet for this study

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 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.

Conditions

  • Eosinophilic Esophagitis

Interventions

DRUG

Beclomethasone dipropionate

Beclomethasone dipropionate 80 mcg two puffs twice daily for 8 weeks

DRUG

placebo

Matched placebo swallowed two puffs twice daily

Sponsors & Collaborators

  • Penn State University

    lead OTHER

Principal Investigators

  • GISOO GHAFFARI, MD · Penn State College of Medicine Hershey Medical Center

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-07-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01016223 on ClinicalTrials.gov