Minimally Invasive Biomarker for Asthma Disease Severity

Completed

• Conditions: Asthma; Healthy

• Registration Number: NCT02225678
• Lead Sponsor: Mayo Clinic

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

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-26
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-13
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sputum Induction	10 minutes	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.

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States