Actively Recruiting

Age: 18Years - 65Years
All Genders
ID06985225

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

Led by University of Kansas Medical Center · Updated on 2026-04-29

5

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Kansas Medical Center

Lead Sponsor

P

Polarean Imaging, Plc

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying patients with severe asthma to understand how mucus plugs in the lungs affect breathing and gas exchange. The study uses CT scans to identify mucus plugs and xenon MRI to assess how these plugs impact lung ventilation and function. This observational research aims to improve knowledge about lung impairment caused by mucus in severe asthma cases. Participants with severe asthma and a high T2 inflammation profile will undergo imaging using a special xenon gas contrast for MRI scans. The study focuses on areas of the lungs downstream of mucus plugs identified by CT imaging. The research does not involve treatment but uses advanced imaging techniques to observe lung function. During the study, participants will have spirometry tests to measure lung function and undergo xenon MRI scans to evaluate ventilation defects. Researchers will monitor ventilation defects in mucus-blocked lung regions over 12 weeks and track changes in ventilation defect percentage at 4 and 12 weeks. The study includes safety screening for MRI compatibility and requires participants to complete informed consent and clinical evaluations.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adequate completion of informed consent process with written documentation
  • Patients 18 to 65 years old
  • Physician diagnosis of asthma for more than 1 year
  • Able to perform reproducible spirometry according to ATS criteria based on clinical PFTs
  • Blood eosinophil count greater than 300 cells/µL and FeNO greater than 25 ppb
  • Smoking history less than 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
Not Eligible

You will not qualify if you...

  • Respiratory tract infection within the 4 weeks prior to Visit 1
  • Body mass index (BMI) greater than 30 at Visit 1
  • One-time doses such as intra-articular injections require a 4-week washout prior to Visit 1
  • Asthma-related emergency room visit within the previous 4 weeks of Visit 1
  • Significant concomitant medical illness including heart disease, cancer, uncontrolled diabetes, other chronic lung diseases
  • Resting oxygen saturation less than 90% with maximum supplemental oxygen delivered by nasal cannula
  • Positive urine pregnancy test at Visit 1 or at any time while on the study
  • Participation in an intervention study or use of investigative drugs within the past 30 days or plans to enroll 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 prohibit MRI scanning as determined by MRI safety screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 12 weeks

Participants undergo MRI imaging with hyperpolarized 129 Xenon to evaluate ventilation defects downstream of mucus plugs.

1 to 3 visits depending on assessments at 4 and 12 weeks

Trial Site Locations

Total: 1 location

1

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

Loading map...

Research Team

C

Cristal Monge

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

3TR Asthma Biologics Cohort (ABC) Study - A Part of the 3TR ...

Severe Asthma

Actively Recruiting

2 locations

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Stud...

Severe Asthma

Actively Recruiting

29 locations

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Stud...

Severe Asthma

Actively Recruiting

14 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here