Clinical trial NCT01170234: Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis
Official title: Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Esophagitis
Keywords: Exhaled nitric oxide
Eosinophilic esophagitis
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 14
Sex: ALL
Minimum age (years): 7
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gastroenterology outpatient clinic

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.


Eligibility criteria: 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

Primary outcomes:
measure: Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis
timeFrame: 2 years
measure: Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis
timeFrame: 2 years
Secondary outcomes:
measure: Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: John Leung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.