Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Severe Asthma
NCT ID: NCT06985225
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5 participants
OBSERVATIONAL
2025-06-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Main Group
Patients with Severe Asthma with a high T2 phenotype
Hyperpolarized 129 Xenon
Xenon gas contrast agent for MRI
Interventions
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Hyperpolarized 129 Xenon
Xenon gas contrast agent for MRI
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Polarean Imaging, Plc
UNKNOWN
University of Kansas Medical Center
OTHER
Responsible Party
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Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY800161495
Identifier Type: -
Identifier Source: org_study_id
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