Eosinophil/Asthma Study

Overview

About this study

The objectives of this study are to correlate concentrations of EDN in serum with peripheral blood eosinophil counts, to compare sensitivity and specificity of serum EDN and peripheral blood eosinophil counts for diagnosis of asthma, and to compare correlation of serum EDN and eosinophil counts with asthma disease severity.  Data collected during this study will submittted to the FDAU and used to support the end goal of FDA approval for this device. 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Study Arm 1 Preschool Children < 6 years old Asthma Group (N=200):

  • Diagnosis of asthma.
  • In the absence of an asthma diagnosis:
    • Persistent wheezing of at least one year;
    • Even distribution of socio-demographics including age, gender, race and ethnicity.

Exclusion Criteria:

  • Actively sick with covid or flu.

Inclusion Criteria - Non-Asthma/Disease Controls (N=200):

  • Diagnosis of allergy.
  • Even distribution of sociodemographics including age, gender, race and ethnicity.

Exclusion Criteria:

  • Diagnosis of asthma.
  • Recurrent wheezing.
  • Actively sick with covid or flu.

Inclusion Criteria - Healthy Controls (N=200): 

  • Not having or suspected of having any known upper/lower respiratory disease.
  • Even distribution of sociodemographics including age, gender, race and ethnicity.

Exclusion Criteria:

  • Diagnosis of asthma or any known upper/lower respiratory disease.
  • Diagnosis of allergy.
  • Actively sick with covid or flu.

Inclusion Criteria - Study Arm 2 Children 6-17 years of age Asthma Group (N=200): 

  • Diagnosis of asthma.
  • In the absence of an asthma diagnosis:
    • Persistent wheezing of at least one year.
  • Even distribution of sociodemographics including age, gender, race and ethnicity.

Exclusion Criteria:

  • Actively sick with covid or flu.  

Inclusion Criteria - Non-Asthma/Disease Controls  (N=200):

  • Diagnosis of allergy. 
  • Even distribution of sociodemographics including age, gender, race and ethnicity.

Exclusion Criteria: 

  • Diagnosis of asthma.
  • Recurrent wheezing.
  • Actively sick with covid or flu.

Inclusion Criteria - Healthy Controls (N=200):

  • Not having or suspected of having any known upper/lower respiratory disease.
  • Even distribution of sociodemographics including age, gender, race and ethnicity. 

Exclusion Criteria: 

  • Diagnosis of asthma or recurrent wheezing.
  • Diagnosis of allergy.
  • Actively sick with covid or flu.

Inclusion Criteria - Study Arm 3  Adults > 18 years old
Asthma Group (N=200):

  • Diagnosis of asthma.
  • Even distribution of sociodemographics including age, gender, race and ethnicity. 

Exclusion Criteria: 

  • Actively sick with covid or flu.  

Inclusion Criteria - Non-Asthma/Disease Controls (N=200):

  • Diagnosis of allergy.
  • Even distribution of sociodemographics including age, gender, race and ethnicity. 

Exclusion Criteria:

  • Diagnosis of asthma.
  • Recurrent wheezing.
  • Actively sick with covid or flu.

Inclusion Criteria - Healthy Controls  (N=200) :

  • Not having or suspected of having any known upper/lower respiratory disease.
  • Even distribution of socio-demographics including age, gender, race and ethnicity.

Exclusion Criteriao: 

  • Diagnosis of asthma.
  • Diagnosis of allergy.
  • Actively sick with covid or flu.

Eligibility last updated 2/18/22. Questions regarding updates should be directed to the study team contact.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Melissa Snyder, Ph.D.

Closed for enrollment

Contact information:

Melissa Snyder Ph.D.

(507) 284-0031

snyder.melissa@mayo.edu

More information

Publications

Publications are currently not available