Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis

There is currently no reliable, noninvasive biomarker for eosinophilic esophagitis (EoE), a chronic allergic diseases characterized by significant infiltration of eosinophils in the esophagus. Because eosinophils release nitric oxide, levels of exhaled nitric oxide (FeNO) are used routinely for guiding treatment in subsets of patients with asthma. FeNO levels are also elevated in immunological diseases that do not involve the airways. The investigators hypothesize that patients with EoE have elevated nitric oxide concentration in their exhaled breath and that changes in FeNO levels could be used to measure disease activity. The objective of this study is to determine the feasibility of using FeNO as a noninvasive surrogate marker for EoE disease activity. The investigators propose to measure serial exhaled nitric oxide (FeNO) levels on a group of patients with confirmed EoE, before, during and after the course of topical corticosteroid therapy to determine whether the level declines from pre-treatment level in individual patients.

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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

7 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age 7-65.
Confirmed diagnosis of EoE. The diagnosis of eosinophilic esophagitis is based upon the presence of characteristic clinical features and large numbers of eosinophils in the esophagus on pathologic examination (≥15 eosinophils per high powered [400x] field in at least one specimen) despite acid suppression with a PPI for one to two months. The criteria also include normal gastric and duodenal mucosal biopsies and the exclusion of other causes. Clinical features in adults include dysphagia, pain and/or history of food impaction. Symptoms in children vary depending in part upon their age: feeding disorders (median age 2.0), vomiting (median age 8.1), abdominal pain (median age 12.0), dysphagia (median age 13.4), and food impaction (median age 16.8).

Exclusion criteria

Use of systemic or inhaled corticosteroids in the preceding 3 months.
History of doctor-diagnosed asthma, acute or chronic rhinosinusitis.
History of cirrhosis.
History of kidney, heart or lung disease.
Pregnancy

Treatment and study plan

NIOX MINO® Airway Inflammation Monitor

Device

We will measure exhaled nitric oxide of patients with eosinophilic esophagitis pre-, during and post- treatment at pre-defined time intervals.

Primary outcomes

Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis

Time frame: 2 years

The objective of this study is to determine the feasibility of using exhaled nitric oxide (FeNO) as a noninvasive surrogate marker for EoE disease activity. We will measure FeNO levels on a group of patients with confirmed EoE before, during and after the course of topical corticosteroid therapy.
Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis

Time frame: 2 years

Change in exhaled nitric oxide levels during corticosteroid treatment.

Secondary outcomes

Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis

Time frame: 2 years

Intra- and inter-patient variability in exhaled nitric oxide levels.

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Jul 27, 2010
Registry last updated: Apr 16, 2019

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.

Published trials that share one or more normalized conditions with this study.

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