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

Mount Sinai Health System

Status: Not yet enrolling

Conditions: Asthma; Type 2 Asthma

Treatments: Diagnostic Test: FeNO Breath Test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07675044

STUDY-26-00373

B6-0373 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

200 participants in 1 patient group

Participants with Asthma

Description:

Individuals with a pre-existing diagnosis of asthma

Treatment:

Diagnostic Test: FeNO Breath Test