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

July 23, 2010
February 28, 2012
August 2010
February 2012   (final data collection date for primary outcome measure)
  • 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.
  • Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis [ Time Frame: 1 year ] [ 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: 1 year ] [ Designated as safety issue: No ]
    Change in exhaled nitric oxide levels during corticosteroid treatment.
Complete list of historical versions of study NCT01170234 on ClinicalTrials.gov Archive Site
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.
Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Intra- and inter-patient variability in exhaled nitric oxide levels.
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Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis
Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Gastroenterology outpatient clinic

Eosinophilic Esophagitis
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.
Eosinophilic esophagitis (EoE)
Treatment-naïve EoE patients, age 7 -65
Intervention: Device: NIOX MINO® Airway Inflammation Monitor
[No authors listed] 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. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
7 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01170234
TUFTS-EOE-FENO
No
John Leung, Tufts Medical Center
Tufts Medical Center
Not Provided
Principal Investigator: John Leung, MD Tufts Medical Center
Tufts Medical Center
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP