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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Muco-Obstructive Lung Disease
- ClinicalTrials.gov ID
- NCT06985225
- Acronym / sponsor ID
- STUDY800161495
- Conditions
- Severe Asthma, COPD, Non-CF Bronchiectasis, Cystic Fibrosis (CF)
- Keywords
- Xenon MRI, Mucus Plug, Severe Asthma, COPD, Non-CF Bronchiectasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Polarean Imaging, Plc
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Group | – | Combination Product: Hyperpolarized 129 XenonPatients with Severe Asthma with a high T2 phenotype |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with muco-obstructive pulmonary disease, including COPD, non-CF bronchiectasis, Severe Asthma, or cystic fibrosis
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized 129 XenonXenon gas contrast agent for MRI | Combination product | Main Group |
Primary outcome
Ventilation Defect in Mucus blocked Regions
Time frame: Baseline
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).
1 secondary outcome
Changes to Gas Exchange with Bronchodilator
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. Images from participants will be shared, alongside pulmonary function testing data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma and COPD, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristal Monge ((913) 945-9399, chernandez@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation Defect in Mucus blocked Regions (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.