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Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

NCT ID: NCT00961233

Last Updated: 2012-11-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Eosinophilic Esophagitis

Keywords

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eosinophilic esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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inhaled/swallowed budesonide

Group Type EXPERIMENTAL

inhaled/swallowed budesonide

Intervention Type DRUG

medication will be nebulized and then swallowed

viscous/swallowed budesonide

Group Type ACTIVE_COMPARATOR

viscous/swallowed budesonide

Intervention Type DRUG

viscous suspension of budesonide will be swallowed

Interventions

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inhaled/swallowed budesonide

medication will be nebulized and then swallowed

Intervention Type DRUG

viscous/swallowed budesonide

viscous suspension of budesonide will be swallowed

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Evan Dellon

MD, MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evan S Dellon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Dellon ES, Sheikh A, Speck O, Woodward K, Whitlow AB, Hores JM, Ivanovic M, Chau A, Woosley JT, Madanick RD, Orlando RC, Shaheen NJ. Viscous topical is more effective than nebulized steroid therapy for patients with eosinophilic esophagitis. Gastroenterology. 2012 Aug;143(2):321-4.e1. doi: 10.1053/j.gastro.2012.04.049. Epub 2012 May 3.

Reference Type DERIVED
PMID: 22561055 (View on PubMed)

Other Identifiers

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IRUSESOM0609

Identifier Type: -

Identifier Source: org_study_id