Eosinophilic EsophagitisNCT01170234
Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 65 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- NIOX MINO® Airway Inflammation Monitor
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Gastroenterology outpatient clinic
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- NIOX MINO® Airway Inflammation Monitor
- Keywords
- Exhaled nitric oxide, Eosinophilic esophagitis
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIOX MINO® Airway Inflammation MonitorDevice
We will measure exhaled nitric oxide of patients with eosinophilic esophagitis pre-, during and post- treatment at pre-defined time intervals.
| Study group | Role | What they receive |
|---|---|---|
| Eosinophilic esophagitis (EoE) | Treatment-naïve EoE patients, age 7 -65 Receives: Device: NIOX MINO® Airway Inflammation Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis
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.
Measured: 2 years
Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis
Change in exhaled nitric oxide levels during corticosteroid treatment.
Measured: 2 years
Secondary outcomes (1)
Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis
Intra- and inter-patient variability in exhaled nitric oxide levels.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Leung, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170234
- Sponsor's protocol ID
- TUFTS-EOE-FENO
- Status last verified
- Apr 2019
- First submitted
- 23 Jul 2010
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1164/ajrccm.160.6.ats8-99. No abstract available.
PubMed 10588636
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT01170234
- Acronym / sponsor ID
- TUFTS-EOE-FENO
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Exhaled nitric oxide, Eosinophilic esophagitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eosinophilic esophagitis (EoE) | – | Device: NIOX MINO® Airway Inflammation MonitorTreatment-naïve EoE patients, age 7 -65 |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Gastroenterology outpatient clinic
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIOX MINO® Airway Inflammation MonitorWe will measure exhaled nitric oxide of patients with eosinophilic esophagitis pre-, during and post- treatment at pre-defined time intervals. | Device | Eosinophilic esophagitis (EoE) |
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.
1 secondary outcome
Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Background: PubMed 10588636Recommendations 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. doi: 10.1164/ajrccm.160.6.ats8-99. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Leung, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled nitric oxide as a biomarker for disease activity in eosinophilic esophagitis (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01170234, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.