Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Severe Asthma

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · May 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how mucus plugs in the lungs affect breathing in people with severe asthma. Researchers will use a special imaging technique called xenon MRI to look at areas of the lungs that might not be working well because of these plugs. Before the MRI, the mucus plugs will be identified using CT scans. The goal is to understand how these plugs impact airflow and gas exchange in the lungs, which can help improve asthma treatments.

To participate in this study, individuals should be between 18 and 65 years old and have been diagnosed with asthma for over a year. They must also be able to perform certain breathing tests and have specific blood results related to their asthma. Participants are expected to undergo imaging tests but will not have to change their current asthma treatments. It's important to note that people with recent respiratory infections, certain health conditions, or those who smoke may not be eligible for this trial. If you or someone you know is interested, this study could provide valuable insights into managing severe asthma more effectively.

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Eligibility criteria

• Inclusion Criteria:
• • Adequate completion of informed consent process with written documentation
• • Patients 18 - 65 years old
• • Physician diagnosis of asthma for \> 1 year
• • Able to perform reproducible spirometry according to ATS criteria based on clinical PFTs.
• • Blood eosinophil count \> 300 cells/μL and FeNO \>25ppb
• • Smoking history \<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
• Exclusion Criteria:
• • Respiratory tract infection within the 4 weeks prior to Visit 1
• • Body mass index (BMI) \> 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
• • Significant concomitant medical illness, including (but not limited to) heart disease, cancer, uncontrolled diabetes, other chronic lung diseases (determined by the Investigator.)
• • Resting O2 saturation \<90% with maximum supplemental O2 delivered by nasal canula
• • Positive urine pregnancy test at Visit 1 or at any time while on the study
• • Participation in an intervention study (including bronchoscopy) 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.