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

April 11, 2019 updated by: Tufts Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Gastroenterology outpatient clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 years
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.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tufts Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Leung, MD, Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TUFTS-EOE-FENO

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