Quantifying the Burden of Type 2 (T2) Inflammation in Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FeNO Breath Test.
- Who it may be relevant to
- Registry conditions: Asthma, Type 2 Asthma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
QUANTAS-PC: Quantifying the Burden of Type 2 (T2) Inflammation in Asthma in Primary Care and Community Specialty Practices
Overview
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 test FeNO 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
Primary outcome measures
- The proportion of patients with FeNO ≥ 25 ppb [Time frame: Day 1]
Secondary outcome measures (2)
- Asthma Control Test (ACT) Score [Time frame: Day 1]
- The proportion of patients with a historical blood eosinophil count ≥ 150 cells/μL [Time frame: Day 1]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Mount Sinai Health System — New York
Identifiers
NCT: NCT07675044 · STUDY-26-00373 · B6-0373