Status:
RECRUITING
Downstream Effects of Airway Mucus Plugs on 129Xenon MRI in Severe Asthma
Lead Sponsor:
Bastiaan Driehuys
Collaborating Sponsors:
University of Kansas Medical Center
Polarean, Inc.
Conditions:
Severe Asthma
Eligibility:
All Genders
18-65 years
Brief Summary
In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with severe asthma. Mucus plugs will be identified using CT imaging, and xeno...
Eligibility Criteria
Inclusion
- 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 within previous 30 days of enrollment
- All racial/ethnic backgrounds may participate
- Blood eosinophil count \> 300 cells/μL
- Smoking history \<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
Exclusion
- 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 or at any time while on the study
- 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 cannula
- 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.
Key Trial Info
Start Date :
November 17 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT07139899
Start Date
November 17 2025
End Date
September 1 2027
Last Update
November 20 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27713