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

Eosinophilic Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170234
• Other study ID #: TUFTS-EOE-FENO
• Status: Completed
• Start date: August 2010
• Est. completion date: February 2012

Study information

• Verified date: April 2019
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Device:
• NIOX MINO® Airway Inflammation Monitor
We will measure exhaled nitric oxide of patients with eosinophilic esophagitis pre-, during and post- treatment at pre-defined time intervals.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis	Change in exhaled nitric oxide levels during corticosteroid treatment.	2 years
Secondary	Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis	Intra- and inter-patient variability in exhaled nitric oxide levels.	2 years