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

NCT01170234 | Completed

• 1 other identifier: TUFTS-EOE-FENO
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eosinophilic Esophagitis

Keywords

Exhaled nitric oxide; Eosinophilic esophagitis

Outcome Measures

Primary Outcomes (2)

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

  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.

  2 years

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

  Change in exhaled nitric oxide levels during corticosteroid treatment.

  2 years

Secondary Outcomes (1)

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

  2 years

Study Arms (1)

Eosinophilic esophagitis (EoE)

Treatment-naïve EoE patients, age 7 -65

Device: NIOX MINO® Airway Inflammation Monitor

Interventions

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.

Eosinophilic esophagitis (EoE)

Eligibility Criteria

• Age: 7 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gastroenterology outpatient clinic

You may qualify if:

• Age 7-65.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Recommendations for standardized procedures for the on-line and off-line measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide in adults and children-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 1999 Dec;160(6):2104-17. doi: 10.1164/ajrccm.160.6.ats8-99. No abstract available.

  PMID: 10588636 BACKGROUND

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

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

Study Officials

• John Leung, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 27, 2010
• Study Start: August 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)