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NCT01929824 Clinical Trial

Nasal Nitric Oxide Levels in Eosinophilic Esophagitis (EoE)

Eosinophilic Esophagitis Clinical Trial

Official title:
A Pilot Study: Nasal Nitric Oxide Levels in Eosinophilic Esophagitis.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01929824
Other study ID # 13-001194
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2013
Est. completion date September 25, 2019

Study information
Verified date September 2019
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is aimed at understanding whether oral nitric oxide levels can be used as a non-invasive marker for the diagnosis and management of patient with eosinophilic esophagitis (EoE).

Description:

Nitric oxide (NO) is produced by activated eosinophils and oral NO levels are known to be elevated in asthma and eosinophilic bronchitis. The measurement of oral NO is a non-invasive,easy to perform low cost procedure that is used frequently in the diagnosis and management of asthma. The diagnosis of eosinophilic esophagitis (EoE) requires conscious sedation, an upper endoscopy with biopsy, and histologic evaluation of the biopsy specimen. This is a costly and somewhat invasive procedure. If oral NO was elevated as a result of activity of esophageal eosinophils in EoE, the measurement of oral NO may potentially be a very convenient and useful test in the evaluation and treatment of EoE. We propose a pilot study to determine if oral NO levels are elevated in patients with eosinophilic esophagitis.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date September 25, 2019
Est. primary completion date September 25, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

- Subjects with dysphagia and active esophageal infiltration (esophageal eosinophilic count of >/= 15 eos/hpf)

- Subjects with or without a clinical diagnosis of asthma

Exclusion criteria:

- Subjects with chronic cough

- Severe CAD

- MI within the last 3 months

- Cystic fibrosis

- Tuberculosis

- Chronic obstructive pulmonary disease (COPD)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Oral Nitric Oxide testing
o Oral nitric oxide is measured by a breathing test where the participant will be seated in a chair and asked to breathe out into a small hand-held instrument for about 6 seconds.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with increase in Oral Nitric Oxide levels To determine if oral NO correlates to activity of disease in EoE one year
See also
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Terminated NCT04543409 - A Study of Benralizumab in Patients With Eosinophilic Esophagitis Phase 3
Completed NCT04941742 - The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
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Completed NCT05084963 - A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis Phase 2
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Recruiting NCT02331849 - Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry. N/A
Active, not recruiting NCT02202590 - Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus N/A
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