Severe AsthmaNCT06985225
Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Muco-Obstructive Lung Disease
An observational study of Severe Asthma and COPD, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with muco-obstructive pulmonary disease. 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Asthma, COPD, Non-CF Bronchiectasis
- What is being tested?
- Hyperpolarized 129 Xenon
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with muco-obstructive pulmonary disease, including COPD, non-CF bronchiectasis, Severe Asthma, or cystic fibrosis
Who may be able to join
- Adequate completion of informed consent process with written documentation
- Patients 18 - 65 years old
- • Physician diagnosis of muco-obstructive pulmonary disease, including cystic fibrosis, severe asthma, chronic obstructive pulmonary disease, or non-cystic fibrosis bronchiectasis for > 1 year
- Able to perform reproducible spirometry according to ATS criteria based on clinical PFTs.
Who cannot join
- 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
- ER visit related to pulmonary condition 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
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- Positive urine pregnancy test
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Cristal Monge, (913) 945-9399, chernandez@kumc.edu
Peter Niedbalski, PhD
About this study
In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with muco-obstructive pulmonary disease. 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, COPD, Non-CF Bronchiectasis, Cystic Fibrosis (CF)
- Being tested
- Hyperpolarized 129 Xenon
- Keywords
- Xenon MRI, Mucus Plug, Severe Asthma, COPD, Non-CF Bronchiectasis
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 129 XenonCombination product
Xenon gas contrast agent for MRI
| Study group | Role | What they receive |
|---|---|---|
| Main Group | Patients with Severe Asthma with a high T2 phenotype Receives: Combination Product: Hyperpolarized 129 Xenon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (1)
Changes to Gas Exchange with Bronchodilator
- The change in regional gas exchange markers following administration of a bronchodilator.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Polarean Imaging, Plc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985225
- Sponsor's protocol ID
- STUDY800161495
- Status last verified
- Jun 2026
- First submitted
- 14 May 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Images from participants will be shared, alongside pulmonary function testing data.