Minimally Invasive Biomarker for Asthma… | Clinical Trial

Key information

Conditions

Asthma Bronchial Diseases Healthy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

Project goals:

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

Proposal Specific Aims:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Sputum Induction

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Aug 26, 2014
Registry last updated: May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed