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

NCT01016223 | Completed Phase 1 DMC

• 1 other identifier: 32508
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Eosinophilic esophagitis; Beclomethasone; Ultrasensitive CRP

Outcome Measures

Primary Outcomes (1)

• Symptom improvement

  5 months

Study Arms (2)

Beclomethasone dipropionate inhaler

ACTIVE COMPARATOR

Drug: Beclomethasone dipropionate

Matched inhaler

PLACEBO COMPARATOR

Drug: placebo

Interventions

Beclomethasone dipropionate DRUG

Beclomethasone dipropionate 80 mcg two puffs twice daily for 8 weeks

Beclomethasone dipropionate inhaler

placebo DRUG

Matched placebo swallowed two puffs twice daily

Matched inhaler

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• GISOO GHAFFARI, MD

  Penn State College of Medicine Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Medicine

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: March 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 30, 2012

Record last verified: 2012-11

Locations

US (1)