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

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 xenon MRI will be used to evaluate ventilation and gas exchange impairments in regions of the lungs corresponding to the airways downstream of mucus plugs.

Study Overview

• Status: Recruiting
• Conditions: Severe Asthma
• Intervention / Treatment: Combination product: Hyperpolarized 129 Xenon

• Study Type: Observational
• Enrollment (Estimated): 5

Contacts and Locations

• Study Contact: Name: Cristal Monge; Phone Number: (913) 945-9399; Email: chernandez@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Cristal Monge; Phone Number: 913-945-9399; Email: chernandez@kumc.edu
      • Principal Investigator: Peter Niedbalski, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with High T2 Severe Asthma

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Main Group; Patients with Severe Asthma with a high T2 phenotype	Combination product: Hyperpolarized 129 Xenon; Xenon gas contrast agent for MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation Defect in Mucus blocked Regions	The primary endpoint of this study is the ventilation defect percent (VDP; measured by Xe-MRI) in regions of the lungs that are downstream of mucus plugs (identified on CT imaging).	12-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VDP	1) The change in VDP downstream of mucus plugs 4-weeks following initiation of biologic therapy.	4-weeks
Long term change in VDP	The change in VDP downstream of mucus plugs 12-weeks following initiation of biologic therapy.	12-weeks

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Polarean Imaging, Plc

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 14, 2025
• First Submitted That Met QC Criteria: May 14, 2025
• First Posted (Actual): May 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Severe Asthma; Xenon MRI; Mucus Plug
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Anesthetics, General; Anesthetics, Inhalation; Xenon
• Other Study ID Numbers: STUDY800161495

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Images from participants will be shared, alongside pulmonary function testing data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No