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NCT01170234 · ClinicalTrials.gov registry record
Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis
A clinical trial, sponsored by Tufts Medical Center.
- Completed
- Registry status
- 14
- Enrollment target
NCT01170234: Completed study, sponsored by Tufts Medical Center.
NCT01170234 is a clinical trial that has completed, run by Tufts Medical Center. The registered enrollment target is 14 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01170234 has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- 14 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE NIOX MINO® Airway Inflammation Monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-02 |
What the finished NCT01170234 record still lists
NCT01170234 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 14 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which NIOX MINO® Airway Inflammation Monitor is the first listed.
NCT01170234 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01170234 about?
NCT01170234 is a clinical study titled "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 guid...
What is the current status of trial NCT01170234?
This trial is currently completed. The enrollment target is 14 participants. The study started on 2010-08. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01170234?
The interventions under investigation include: NIOX MINO® Airway Inflammation Monitor (DEVICE).
Who is sponsoring clinical trial NCT01170234?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
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