Asthma, Type 2 Asthma
Conditions
Keywords
Asthma, Eosinophils, Exhaled Nitric Oxide
Brief summary
This study is designed to support the assessment of Type 2 (T2) biomarkers in asthma in primary care and community specialty practices. To assess T2 biomarkers, individuals will be required to complete a breath test for fractional exhaled nitric oxide (FeNO) and consent to a review of their medical records. Asthma often goes undetected in primary care and community settings, and through this study the researchers hope to optimize referral pathways to care.
Interventions
DIAGNOSTIC_TESTFeNO Breath Test
Fractional Exhaled Nitric Oxide (FeNO) test breathing test that measures the amount of nitric oxide in exhaled breath to detect airway inflammation, aiding in the diagnosis and management of asthma
Sponsors
Icahn School of Medicine at Mount Sinai
Sanofi
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant Inclusion Criteria * Age 18 years and older * Ability to consent and comply with protocol assessments * Pre-existing diagnosis of asthma and has started treatment Participant
Exclusion criteria
* Participant deemed medically ineligible per the opinion of the investigator * History of respiratory/lung disease other than asthma (e.g., COPD, emphysema, chronic bronchitis, tuberculosis, cystic fibrosis, lung cancer, recurrent pneumonia or other chronic lung disease) * Participants who meet criteria for GINA 5, severe asthma (ICS + additional controllers) * Current Enrollment in an asthma intervention trial that could affect asthma outcomes clinically and T2 biomarkers * Visit with a specialist (i.e. Pulmonologist or Allergist) in the past year who is measuring FeNO levels
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with FeNO ≥ 25 ppb | Day 1 | The proportion of patients with FeNO ≥ 25 ppb will be measured by using a hand-held portable machine at a standard flow rate of 50 mL/s. FeNO levels serve as a biomarker for Type 2 airway inflammation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test (ACT) Score | Day 1 | Baseline Asthma Control Test (ACT) is a tool for identifying those with poorly controlled asthma. Baseline ACT is scored on a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score \>19 indicates well-controlled asthma. |
| The proportion of patients with a historical blood eosinophil count ≥ 150 cells/μL | Day 1 | The proportion of patients with a historical blood eosinophil count ≥ 150 cells/μL. An eosinophil count is blood test that measures the number of eosinophils, a type of white blood cell, |
Countries
United States
Contacts
CONTACTJessica Harris, NP
CONTACTLinda Rogers, MD
PRINCIPAL_INVESTIGATORMonica Kraft, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed