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| ID | Type | Description | Link |
|---|---|---|---|
| B6-0373 | Other Grant/Funding Number | GCO |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Asthma | Individuals with a pre-existing diagnosis of asthma |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FeNO Breath Test | Diagnostic 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with FeNO ≥ 25 ppb | 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Test (ACT) Score | 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. |
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Participant Inclusion Criteria
Participant Exclusion Criteria
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Individuals age 18 with a pre-existing diagnosis of asthma and has started treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Harris, NP | Contact | 212-241-5656 | jessica.harris2@mssm.edu | |
| Linda Rogers, MD | Contact | 212-241-5656 | linda.rogers@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Monica Kraft, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Health System | New York | New York | 10029 | United States |
Observational study
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Day 1 |
| The proportion of patients with a historical blood eosinophil count ≥ 150 cells/μL | 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, | Day 1 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |