Actively Recruiting
Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Severe Asthma
Led by University of Kansas Medical Center · Updated on 2026-04-29
5
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Kansas Medical Center
Lead Sponsor
P
Polarean Imaging, Plc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with severe asthma to understand how mucus plugs in the lungs affect breathing and gas exchange. The study uses CT scans to identify mucus plugs and xenon MRI to assess how these plugs impact lung ventilation and function. This observational research aims to improve knowledge about lung impairment caused by mucus in severe asthma cases. Participants with severe asthma and a high T2 inflammation profile will undergo imaging using a special xenon gas contrast for MRI scans. The study focuses on areas of the lungs downstream of mucus plugs identified by CT imaging. The research does not involve treatment but uses advanced imaging techniques to observe lung function. During the study, participants will have spirometry tests to measure lung function and undergo xenon MRI scans to evaluate ventilation defects. Researchers will monitor ventilation defects in mucus-blocked lung regions over 12 weeks and track changes in ventilation defect percentage at 4 and 12 weeks. The study includes safety screening for MRI compatibility and requires participants to complete informed consent and clinical evaluations.
CONDITIONS
Brief Title
Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With 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
- Blood eosinophil count greater than 300 cells/µL and FeNO greater than 25 ppb
- Smoking history less than 10 pack years
- No smoking history (including vapes, cigar, or marijuana use) in the last 3 months
- Approved for 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 emergency room visit within the previous 4 weeks of Visit 1
- Significant concomitant medical illness including heart disease, cancer, uncontrolled diabetes, 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 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 prohibit MRI scanning as determined by 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 - Up to 12 weeks
Participants undergo MRI imaging with hyperpolarized 129 Xenon to evaluate ventilation defects downstream of mucus plugs.
1 to 3 visits depending on assessments at 4 and 12 weeks
Trial Site Locations
Total: 1 location
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
Research Team
C
Cristal Monge
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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