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Minimally Invasive Biomarker for Asthma Disease Severity

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02225678
Enrollment
25
Registered
2014-08-26
Start date
2014-07-31
Completion date
2015-06-30
Last updated
2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Healthy

Keywords

healthy volunteers, asthma, sputum eosinophils

Brief summary

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

Detailed 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

Interventions

None listed

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Sputum Induction10 minutesPrimary 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026