Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Evan Dellon, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00961233
First received: August 14, 2009
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

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 Intervention
Eosinophilic Esophagitis
Drug: inhaled/swallowed budesonide
Drug: viscous/swallowed budesonide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Tissue Eosinophil Counts [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment


Secondary Outcome Measures:
  • Adrenal Insufficiency [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 25
Study Start Date: October 2009
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961233

Locations
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
Principal Investigator: Evan S Dellon, MD, MPH University of North Carolina, Chapel Hill
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Evan Dellon, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00961233     History of Changes
Other Study ID Numbers: IRUSESOM0609
Study First Received: August 14, 2009
Results First Received: September 4, 2012
Last Updated: November 2, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
eosinophilic esophagitis

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 24, 2014