Minimally Invasive Biomarker for Asthma Disease Severity

NCT ID: NCT02225678

Last Updated: 2016-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-06-30

Brief Summary

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

Detailed Description

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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

Conditions

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Asthma Healthy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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James J. Lee, Ph.D.

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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14-001168

Identifier Type: -

Identifier Source: org_study_id

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