Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

Eosinophilic Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961233
• Other study ID #: IRUSESOM0609
• Status: Completed
• Phase: N/A
• First received: August 14, 2009
• Last updated: November 2, 2012
• Start date: October 2009
• Est. completion date: November 2011

Study information

• Verified date: November 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• inhaled/swallowed budesonide
medication will be nebulized and then swallowed
• viscous/swallowed budesonide
viscous suspension of budesonide will be swallowed

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue Eosinophil Counts	Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment	8 weeks	No
Secondary	Adrenal Insufficiency	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.	8 weeks	Yes