Hyperpolarized 129XeMRI Imaging for Severe Asthma in Obesity

Overseen By Jessica Shier

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bastiaan Driehuys

Must be taking: ICS, ICS/LABA, LAMA

Must not be taking: Systemic corticosteroids

Disqualifiers: Heart disease, Cancer, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

40% of all asthma patients in the US are obese. Obese asthmatics have more severe disease than lean asthmatics and do not respond as well to conventional anti-inflammatory therapies. This proposal will utilize 3D functional imaging with 129XeMRI and single cell RNA sequencing to study mechanisms driving regional airway remodeling and fibrosis in obese asthma subjects and in preclinical models of obese asthma.

Who Is on the Research Team?

Loretta Que, MD

Principal Investigator

Duke

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with asthma and a BMI ≥30 kg/m2, who have been on stable asthma medication for at least 3 months. Non-smokers or those who haven't smoked in the last 3 months are eligible. Participants must be able to perform spirometry tests and give informed consent. Pregnant women, individuals with significant illnesses like heart disease or uncontrolled diabetes, or those unable to complete study assessments are excluded.

Inclusion Criteria

You have a negative result on an allergy skin test.

Your breath test result shows high levels of FeNO (a marker for inflammation in the lungs) at the start of the study.

Your lung function test results show that you don't have asthma.

Exclusion Criteria

Non-Asthma Cohort: Study intervention poses undue risk to patient in the opinion of the Investigator

I have had bronchial thermoplasty for my asthma.

If you are a woman, you are pregnant when you start the study or become pregnant during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Baseline Assessment

Participants undergo 3D functional imaging with 129XeMRI and baseline assessments to identify airway remodeling and fibrosis

4 weeks

1 visit (in-person)

Treatment

Participants receive interventions based on imaging results to study mechanisms driving regional airway remodeling and fibrosis

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 129XeMRI

Trial Overview The trial is studying how obesity affects severe asthma by using advanced imaging called Hyperpolarized 129XeMRI and single cell RNA sequencing. It aims to understand airway remodeling and fibrosis in obese asthmatics compared to lean ones, potentially leading to better treatments.

How Is the Trial Designed?

Group I: Obese Asthmatics Experimental Treatment 1 Intervention

Obese patients that come to Duke that have been diagnosed with Asthma will be approached.

Group II: Obese Non-Asthmatics Active Control 1 Intervention

The obese non-asthmatics will be collected from an IRB pre-approved Healthy Volunteer Data Repository.

Who Is Running the Clinical Trial?

Bastiaan Driehuys

Lead Sponsor

Trials

15

Recruited

1,100+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+