Actively Recruiting
Downstream Effects of Airway Mucus Plugs on 129Xenon MRI Following Biologic Therapy
Led by Bastiaan Driehuys · Updated on 2025-11-20
5
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
B
Bastiaan Driehuys
Lead Sponsor
U
University of Kansas Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of mucus plugs in the lungs of patients with severe asthma using xenon MRI. This imaging technique will be used alongside CT scans to identify mucus plugs and evaluate how they affect lung ventilation and gas exchange in affected regions. The study focuses on understanding lung function impairments caused by these mucus plugs in people with severe asthma. The study involves pulmonary magnetic resonance imaging using hyperpolarized xenon-129 gas as an inhaled contrast agent to assess lung function. Patients who are about to start asthma therapy with biologic treatments such as dupilumab, tezepelumab, or benralizumab as part of their usual care will be observed. The imaging will help detect ventilation defects in lung regions downstream of mucus blockages. Participants will undergo imaging assessments including xenon MRI and CT scans to evaluate ventilation defects and changes over time. Researchers will measure ventilation defects in mucus-blocked regions at 12 weeks, with additional evaluations of ventilation defect percentage changes at 4 and 12 weeks. The study includes careful monitoring of lung function and safety assessments. The total participation period includes these imaging and functional assessments to understand the impact of mucus plugs in severe asthma.
CONDITIONS
Brief Title
Downstream Effects of Airway Mucus Plugs on 129Xenon MRI in Severe Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adequate completion of informed consent process with written documentation
- Patients 18 to 65 years old
- Physician diagnosis of asthma for more than 1 year
- Able to perform reproducible spirometry according to ATS criteria based on clinical PFTs within previous 30 days of enrollment
- All racial and ethnic backgrounds may participate
- Blood eosinophil count greater than 300 cells/µL
- Smoking history less than 10 pack years
- No smoking history (including vapes, cigar, or marijuana use) in the last 3 months
- About to initiate asthma therapy with either dupilumab, tezepelumab, or benralizumab as part of their standard of care
You will not qualify if you...
- Respiratory tract infection within the 4 weeks prior to Visit 1
- Body mass index (BMI) greater than 30 at Visit 1
- One-time doses such as intra-articular injections require a 4-week washout prior to Visit 1
- Asthma-related ER visit within the previous 4 weeks of Visit 1 or at any time while on the study
- Significant concomitant medical illness, including heart disease, cancer, uncontrolled diabetes, or other chronic lung diseases
- Resting oxygen saturation less than 90% with maximum supplemental oxygen delivered by nasal cannula
- Positive urine pregnancy test at Visit 1 or at any time while on the study
- Participation in an intervention study or use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study
- Unable or unlikely to complete study assessments in the opinion of the Investigator
- Study intervention poses undue risk to patient in the opinion of the Investigator
- Conditions that will prohibit MRI scanning determined by the MRI safety screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants undergo pulmonary magnetic resonance imaging using hyperpolarized xenon-129 gas as an inhaled contrast agent to assess airway mucus plugs.
3 visits over 12 weeks
Duration - Up to 12 weeks
Participants are observed over time to track changes in ventilation defects after initiating biologic therapy as part of routine care.
Follow-up visits as scheduled up to 12 weeks
Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27713
Actively Recruiting
Research Team
D
David Mummy, PhD
B
Bastiaan Driehuys, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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