Health TrialsbyHealthPanel

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

ConditionsAsthmaType 2 Asthma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to consent and comply with protocol assessments

Pre-existing diagnosis of asthma and has started treatment

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Participants with Asthma1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1

Secondary outcomes

1

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.

Time frame
Day 1
2

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,

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Sanofi

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: