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NCT Number: NCT07675044

Quantifying the Burden of Type 2 (T2) Inflammation in Asthma

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Type 2 Asthma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. The proportion of patients with FeNO ≥ 25 ppb

    Time frame: 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 outcomes

  1. Asthma Control Test (ACT) Score

    Time frame: 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.

  2. The proportion of patients with a historical blood eosinophil count ≥ 150 cells/μL

    Time frame: 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,

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Harris, NP

CONTACT

[email protected]

212-241-5656

Linda Rogers, MD

CONTACT

[email protected]

212-241-5656

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Sanofi

Registry information

Official study title

QUANTAS-PC: Quantifying the Burden of Type 2 (T2) Inflammation in Asthma in Primary Care and Community Specialty Practices

Acronym: QUANTAS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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