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

NCT06985225 | Recruiting FDA Drug

• 1 other identifier: STUDY800161495
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Severe Asthma

Keywords

Xenon MRI; Mucus Plug; Severe Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in VDP

  4-weeks

• Long term change in VDP

  12-weeks

Study Arms (1)

Main Group

Patients with Severe Asthma with a high T2 phenotype

Combination Product: Hyperpolarized 129 Xenon

Interventions

Hyperpolarized 129 Xenon COMBINATION_PRODUCT

Xenon gas contrast agent for MRI

Main Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with High T2 Severe Asthma

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Polarean Imaging, Plc: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Cristal Monge

CONTACT

(913) 945-9399; chernandez@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)