NCT01929824

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

4.2 years

First QC Date

August 14, 2013

Last Update Submit

September 26, 2019

Conditions

Eosinophilic Esophagitis

Keywords

dysphagia, trouble swallowing, chest pain

Outcome Measures

Primary Outcomes (1)

  • Number of patients with increase in Oral Nitric Oxide levels

    To determine if oral NO correlates to activity of disease in EoE

    one year

Interventions

Oral Nitric Oxide testingOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with eosinophilic esophagitis

You may qualify if:

  • Subjects with dysphagia and active esophageal infiltration (esophageal eosinophilic count of \>/= 15 eos/hpf)
  • Subjects with or without a clinical diagnosis of asthma

You may not qualify if:

  • Subjects with chronic cough
  • Severe CAD
  • MI within the last 3 months
  • Cystic fibrosis
  • Tuberculosis
  • Chronic obstructive pulmonary disease (COPD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Eosinophilic EsophagitisDeglutition DisordersChest Pain

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vivek Iyer, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2013

First Posted

August 28, 2013

Study Start

August 1, 2013

Primary Completion

September 25, 2017

Study Completion

September 25, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations

US(1)