Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE) - Full Text View

Sponsor:	University of North Carolina, Chapel Hill
Collaborator:	AstraZeneca
Information provided by:	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:	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:

MedlinePlus related topics: Esophagus Disorders

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by 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:	November 2011
Estimated 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

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

Responsible Party:	Evan S. Dellon, MD MPH, University of North Carolina School of Medicine
ClinicalTrials.gov Identifier:	NCT00961233 History of Changes
Other Study ID Numbers:	IRUSESOM0609
Study First Received:	August 14, 2009
Last Updated:	July 12, 2011
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 February 09, 2012