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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Leung, Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01170234
First received: July 23, 2010
Last updated: February 28, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Eosinophilic Esophagitis
 Device: NIOX MINO® Airway Inflammation Monitor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in exhaled nitric oxide levels during corticosteroid treatment.


Secondary Outcome Measures:
  • Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Intra- and inter-patient variability in exhaled nitric oxide levels.


Enrollment: 14
Study Start Date: August 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Eosinophilic esophagitis (EoE)
Treatment-naïve EoE patients, age 7 -65
 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.

  Eligibility

Ages Eligible for Study:   7 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Gastroenterology outpatient clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170234

Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: John Leung, MD Tufts Medical Center
  More Information

Publications:

Responsible Party: John Leung, MD, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01170234     History of Changes
Other Study ID Numbers: TUFTS-EOE-FENO
Study First Received: July 23, 2010
Last Updated: February 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
Exhaled nitric oxide
Eosinophilic esophagitis

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013