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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gisoo Ghaffari, Penn State University
ClinicalTrials.gov Identifier:
NCT01016223
First received: November 18, 2009
Last updated: November 29, 2012
Last verified: November 2012

November 18, 2009
November 29, 2012
March 2010
July 2012   (final data collection date for primary outcome measure)
Symptom improvement [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01016223 on ClinicalTrials.gov Archive Site
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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
Not Provided

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Eosinophilic Esophagitis
  • Drug: Beclomethasone dipropionate
    Beclomethasone dipropionate 80 mcg two puffs twice daily for 8 weeks
  • Drug: placebo
    Matched placebo swallowed two puffs twice daily
  • Active Comparator: Beclomethasone dipropionate inhaler
    Intervention: Drug: Beclomethasone dipropionate
  • Placebo Comparator: Matched inhaler
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion criteria:

  • 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01016223
32508
Yes
Gisoo Ghaffari, Penn State University
Penn State University
Not Provided
Principal Investigator: GISOO GHAFFARI, MD Penn State College of Medicine Hershey Medical Center
Penn State University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP