Evaluating Adrenal Insufficiency in Adults With Eosinophilic Esophagitis

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05246085
Study type	Observational
Source	University of Colorado, Denver
Contact	Christopher M Haydek, MD
Phone	(720) 848-2777
Email	christopher.haydek@cuanschutz.edu
Status	Recruiting
Phase
Start date	August 10, 2022
Completion date	July 1, 2023

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See also
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Active, not recruiting	`NCT02202590` - Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus	N/A
Active, not recruiting	`NCT05176249` - Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms