NCT02225678

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

11 months

First QC Date

July 24, 2014

Last Update Submit

May 13, 2016

Conditions

AsthmaHealthy

Keywords

healthy volunteersasthmasputum eosinophils

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

asthma patients healthy volunteers

You may qualify if:

  • Provider diagnosed asthma
  • FeNO\>50 ppb
  • FEV1 \> 1.0 Liter

You may not qualify if:

  • COPD by history
  • Bronchiectasis by history
  • Pregnant participants
  • Normal subjects:
  • \- Age matched to asthma subjects
  • Any eosinophil disorder by history
  • Asthma by history
  • Rhinitis or sinusitis by history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

sputum

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • James Lee, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

July 24, 2014

First Posted

August 26, 2014

Study Start

July 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

US(1)