Minimally Invasive Biomarker for Asthma Disease Severity

Mayo Clinic25 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Asthma Healthy

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: 10 minutes

Data from ClinicalTrials.gov

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