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NCT02225678 Clinical Trial

Minimally Invasive Biomarker for Asthma Disease Severity

Healthy Clinical Trial

Official title:
Feasibility of Using an Eosinophil-Specific Biomarker-(Eosinophil Peroxidase) in Clinical Practice

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02225678
Other study ID # 14-001168
Secondary ID
Status Enrolling by invitation
Phase N/A
First received July 24, 2014
Last updated February 19, 2015
Start date July 2014
Est. completion date December 2015

Study information
Verified date February 2015
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Can a clinical test be developed that could help manage asthma symptoms?

Description:

Project goals:

Develop a point-of-service assay to assess eosinophilic airway inflammation

Proposal Specific Aims:

1. To establish the infrastructure and test the feasibility of sputum collection in a clinical setting as a minimally invasive patient sampling process for biomarker testing

2. To transform the laboratory-based eosinophil peroxidase (EPX) ELISA detection assay into a clinic-friendly assessment that does not require sophisticated laboratory equipment

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 20
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Asthma subjects:

Inclusion

- Provider diagnosed asthma

- FeNO>50 ppb

- FEV1 > 1.0 Liter

Exclusion

- COPD by history

- Bronchiectasis by history

- Pregnant participants

Normal subjects:

Inclusion

- Age matched to asthma subjects

Exclusion

- Any eosinophil disorder by history

- Asthma by history

- Rhinitis or sinusitis by history

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sputum Induction Primary Outcome measure via EPX levels (at point of care) in the sputum of asthma patients and control subjects as a means of demonstrating the ability to use this biomarker approach in a clinical setting. 10 minutes Yes
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