Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

This study is currently recruiting participants.

Verified by The University of North Carolina, Chapel Hill, December 2009

First Received: August 14, 2009 Last Updated: December 1, 2009 History of Changes

Sponsor:	The University of North Carolina, Chapel Hill
Collaborator:	AstraZeneca
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00961233

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Esophagus Disorders

Drug Information available for: Budesonide

U.S. FDA Resources

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

Primary Outcome Measures:

The primary endpoints are: 1) percent decrease in tissue eosinophil counts; and 2) absolute improvement on dysphagia symptom scores. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary endpoints are: 1) Cortisol stimulation test results and adrenocorticotropic hormone levels; and 2) Serum budesonide screen results. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	October 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
inhaled/swallowed budesonide: Experimental	Drug: inhaled/swallowed budesonide medication will be nebulized and then swallowed
viscous/swallowed budesonide: Active Comparator	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

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

Contacts

Contact: Courtney Ziefle

919-966-4591

cziefle@med.unc.edu

Locations

United States, North Carolina
University of North Carolina	Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Courtney Ziefle
Principal Investigator: Evan S Dellon, MD, MPH

Sponsors and Collaborators

The University of North Carolina, Chapel Hill

AstraZeneca

Investigators

Principal Investigator:

Evan S Dellon, MD, MPH

UNC

More Information

No publications provided

Responsible Party:	University of North Carolina School of Medicine ( Evan S. Dellon, MD MPH )
Study ID Numbers:	IRUSESOM0609
Study First Received:	August 14, 2009
Last Updated:	December 1, 2009
ClinicalTrials.gov Identifier:	NCT00961233 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by The University of North Carolina, Chapel Hill:

eosinophilic esophagitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Hormones
Glucocorticoids

Pharmacologic Actions
Esophagitis
Digestive System Diseases
Autonomic Agents
Therapeutic Uses
Esophageal Diseases
Peripheral Nervous System Agents
Gastroenteritis
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 08, 2010