Evaluating Adrenal Insufficiency in Adults With Eosinophilic Esophagitis on Chronic Swallowed Topical Steroids

Eosinophilic Esophagitis Clinical Trial

Official title:

Evaluating Adrenal Insufficiency in Adults With Eosinophilic Esophagitis on Chronic Swallowed Topical Steroids

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246085
• Other study ID #: Protocol 21-4826
• Secondary ID: UL1TR001082
• Status: Recruiting
• Start date: August 10, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: May 2023
• Source: University of Colorado, Denver
• Contact: Christopher M Haydek, MD
• Phone: (720) 848-2777
• Email: christopher.haydek[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus, is a clinical and financial burden to patients if left untreated. Often the natural history of the disease includes development of fibrosis and stricturing of the esophagus, acute food impactions, unplanned emergency room visits, and invasive procedures such as endoscopy. Currently there are no Food and Drug Administration (FDA) approved medications for the treatment of EoE. As such, pharmacologic options approved for use in asthma are used for treatment of EoE and include proton pump inhibitors and swallowed topical steroids. These medications are prescribed chronically as EoE is considered a lifelong disease. Chronic administration of exogenous steroids, when given in inhaled or systemic preparations, can lead to adrenal insufficiency (AI). AI is seen in 7.8% of patients receiving chronic inhaled steroids and 48.7% of patients receiving chronic systemic steroids. The administration of steroids in EoE is unique, as patients typically swallow topical preparations of the drug. The risk of secondary AI from taking swallowed topical steroids is currently unknown, as there has been no study in an adult population assessing this risk as a primary endpoint. Pediatric studies of patients with EoE have shown the risk of AI from swallowed topical steroids to be 5-10%. Based on the risk of AI with inhaled steroids (7.8% prevalence) and the prevalence of AI from swallowed topical steroids in pediatric populations (5-10%), we hypothesize that the risk with swallowed topical steroids is >5%. This could warrant consideration of screening given the potentially serious consequences of undiagnosed AI. To address this hypothesis, this project aims to define the prevalence of developing AI in adults with EoE taking swallowed topical steroids and compare that prevalence to a similar control population of adults with EoE who are taking proton pump inhibitors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 300 adult male or female patients between 18 and 85 years of age with a diagnosis of eosinophilic esophagitis who have been on swallowed topical steroids or proton pump inhibitor therapy (any dosing) for at least 3 months.

Exclusion Criteria:

• We will exclude control patients on proton pump inhibitor therapy if they have used any form of exogenous steroids within the past one year.

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Eosinophilic Esophagitis
• Esophagitis

Intervention

Diagnostic Test:
• Cortisol level
Cortisol levels will be checked in both groups to screen for adrenal insufficiency.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of adrenal insufficiency	Low cortisol level that is confirmed using an adrenocorticotropic hormone stimulation test.	1 year