AsthmaQUANTASNCT07675044
Quantifying the Burden of Type 2 (T2) Inflammation in Asthma
An observational study of Asthma and Type 2 Asthma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Type 2 Asthma
- What is being tested?
- FeNO Breath Test
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals age 18 with a pre-existing diagnosis of asthma and has started treatment.
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mount Sinai Health System
New York, New York, 10029
Jessica Harris, NP, 212-241-5656, jessica.harris2@mssm.edu
Linda Rogers, MD, 212-241-5656, linda.rogers@mssm.edu
About this study
Official title: QUANTAS-PC: Quantifying the Burden of Type 2 (T2) Inflammation in Asthma in Primary Care and Community Specialty Practices
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.
- Conditions
- Asthma, Type 2 Asthma
- Being tested
- FeNO Breath Test
- Keywords
- Asthma, Eosinophils, Exhaled Nitric Oxide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeNO Breath TestDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Participants with Asthma | Individuals with a pre-existing diagnosis of asthma Receives: Diagnostic Test: FeNO Breath Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
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.
Measured: 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,
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Monica Kraft, Icahn School of Medicine at Mount Sinai
- Investigators
- Monica Kraft, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675044
- Sponsor's protocol ID
- STUDY-26-00373
- Other IDs
- B6-0373
- Acronym
- QUANTAS
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Observational study