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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma; Type 2 Asthma
• Intervention / Treatment: Diagnostic test: FeNO Breath Test

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jessica Harris, NP; Phone Number: 212-241-5656; Email: jessica.harris2@mssm.edu
• Study Contact Backup: Name: Linda Rogers, MD; Phone Number: 212-241-5656; Email: linda.rogers@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Health System
      • Principal Investigator: Monica Kraft
      • Contact: Jessica Harris, NP; Phone Number: 212-241-5656; Email: jessica.harris2@mssm.edu
      • Contact: Linda Rogers, MD; Phone Number: 212-241-5656; Email: linda.rogers@mssm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals age 18 with a pre-existing diagnosis of asthma and has started treatment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with Asthma; Individuals with a pre-existing diagnosis of asthma	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Sanofi
• Investigators: Principal Investigator: Monica Kraft, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; Eosinophils; Exhaled Nitric Oxide
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: STUDY-26-00373; B6-0373 (Other Grant/Funding Number: GCO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Observational study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No