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Completed

NCT Number: NCT00961233

Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

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.

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Key information

Conditions

Eosinophilic Esophagitis Digestive System Diseases Eosinophilia Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inhaled/swallowed budesonide

Drug

medication will be nebulized and then swallowed

viscous/swallowed budesonide

Drug

viscous suspension of budesonide will be swallowed

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE): Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 18, 2009
Registry last updated
Nov 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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