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Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00961233
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : November 4, 2012
Last Update Posted : November 6, 2012
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Evan Dellon, University of North Carolina, Chapel Hill

Study Description
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Brief Summary:
The purpose of this study is to conduct a clinical trial of two formulations of budesonide (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if medication contact time and distribution in the esophagus relates to treatment response. The investigators will also determine if there is systemic absorption of these topical steroids. The investigators hypothesize that tissue and symptom response will correlate with esophageal medication contact time and distribution, and that significant systemic absorption will not be seen.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: inhaled/swallowed budesonide Drug: viscous/swallowed budesonide Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE): Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis.
Study Start Date : October 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arms and Interventions
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Arm Intervention/treatment
Experimental: inhaled/swallowed budesonide Drug: inhaled/swallowed budesonide
medication will be nebulized and then swallowed
Active Comparator: viscous/swallowed budesonide Drug: viscous/swallowed budesonide
viscous suspension of budesonide will be swallowed


Outcome Measures
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Primary Outcome Measures :
  1. Tissue Eosinophil Counts [ Time Frame: 8 weeks ]
    Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment


Secondary Outcome Measures :
  1. Adrenal Insufficiency [ Time Frame: 8 weeks ]
    Adrenal insufficiency as measured by a standard cortisol stimulation test (using 0.25 mg cosyntropin IV and baseline and 60 minute post-injection serum cortisol measurements) after treatment. A rise in serum cortisol concentration after to a peak of ≥18 mcg/dL was considered normal; a smaller rise than this was considered adrenal insufficiency.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New diagnosis of eosinophilic esophagitis (per 2007 consensus guidelines)

Exclusion Criteria:

  • Age < 18
  • Inability to read or understand English
  • Pregnant or nursing women
  • Previous allergic reactions to steroid medications
  • Current use of systemic steroids
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961233


Locations
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United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
AstraZeneca
Investigators
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Principal Investigator: Evan S Dellon, MD, MPH University of North Carolina, Chapel Hill
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Evan Dellon, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00961233    
Other Study ID Numbers: IRUSESOM0609
First Posted: August 18, 2009    Key Record Dates
Results First Posted: November 4, 2012
Last Update Posted: November 6, 2012
Last Verified: November 2012
Keywords provided by Evan Dellon, University of North Carolina, Chapel Hill:
eosinophilic esophagitis
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists