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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01170234 |
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Date of registration:
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23/07/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis
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Scientific title:
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Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01170234 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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John Leung, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tufts Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
7 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Eosinophilic Esophagitis
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Intervention(s)
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Device: NIOX MINO® Airway Inflammation Monitor
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Primary Outcome(s)
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Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis
[Time Frame: 2 years]
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Secondary Outcome(s)
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Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis
[Time Frame: 2 years]
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Secondary ID(s)
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TUFTS-EOE-FENO
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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