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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: Tufts Medical Center

Current Primary Outcome:

  • 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.
  • 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.


Original Primary Outcome:

  • Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis [ Time Frame: 1 year ]
    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: 1 year ]
    Change in exhaled nitric oxide levels during corticosteroid treatment.


Current Secondary Outcome: 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.


Original Secondary Outcome: Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis [ Time Frame: 1 year ]

Intra- and inter-patient variability in exhaled nitric oxide levels.


Information By: Tufts Medical Center

Dates:
Date Received: July 23, 2010
Date Started: August 2010
Date Completion:
Last Updated: February 28, 2012
Last Verified: February 2012