Severe AsthmaNCT07139899
Downstream Effects of Airway Mucus Plugs on 129Xenon MRI in Severe Asthma
An observational study of Severe Asthma, run by Bastiaan Driehuys 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 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Asthma
- What is being tested?
- Hyperpolarized Xenon 129
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to Sep 2027
- 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 High T2 Severe Asthma
Who may be able to join
- 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 within previous 30 days of enrollment
- All racial/ethnic backgrounds may participate
- Blood eosinophil count > 300 cells/μL
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- Smoking history <10 pack years
- No smoking history (including vapes, cigar, or marijuana use) in the last 3 months
- About to initiate asthma therapy with either dupilumab, tezepelumab, or benralizumab as part of their standard of care
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
- Asthma-related ER visit within the previous 4 weeks of Visit 1 or at any time while on the study
- 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 cannula
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- 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.
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
Duke University Medical Center
Durham, North Carolina, 27713
About this study
Official title: Downstream Effects of Airway Mucus Plugs on 129Xenon MRI Following Biologic Therapy
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
- Being tested
- Hyperpolarized Xenon 129
- Keywords
- xenon, asthma, mucus
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Xenon 129Combination product
Pulmonary magnetic resonance imaging using hyperpolarized xenon-129 gas as an inhaled contrast agent
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: 12 weeks
Secondary outcomes (2)
Change in VDP
The change in VDP downstream of mucus plugs 4 weeks following initiation of biologic therapy.
Measured: 4 weeks
Long term change in VDP
Change in VDP downstream of mucus plugs 12 weeks following initiation of biologic therapy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start17 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionSep 2027 (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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bastiaan Driehuys
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center, Polarean, Inc.
- Responsible party
- Sponsor-investigator, Bastiaan Driehuys, Duke University
- Investigators
- David Mummy, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139899
- Sponsor's protocol ID
- Pro00117680
- Status last verified
- Nov 2025
- First submitted
- 18 Aug 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Images from participants will be shared, alongside pulmonary function testing data and basic demographics.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Downstream Effects of Airway Mucus Plugs on 129Xenon MRI Following Biologic Therapy
- ClinicalTrials.gov ID
- NCT07139899
- Acronym / sponsor ID
- Pro00117680
- Conditions
- Severe Asthma
- Keywords
- xenon, asthma, mucus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Bastiaan DriehuysUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center, Polarean, Inc.
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Aug 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with High T2 Severe Asthma
Key inclusion criteria (9 listed)
- 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 within previous 30 days of enrollment
- All racial/ethnic backgrounds may participate
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
- Asthma-related ER visit within the previous 4 weeks of Visit 1 or at any time while on the study
- 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 Xenon 129Pulmonary magnetic resonance imaging using hyperpolarized xenon-129 gas as an inhaled contrast agent | Combination product | – |
Primary outcome
Ventilation Defect in Mucus-blocked regions
Time frame: 12 weeks
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).
2 secondary outcomes
Change in VDP
Time frame: 4 weeks
Long term change in VDP
Time frame: 12 weeks
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 20 Nov 2025.
- Individual participant dataSharing planned: Yes. Images from participants will be shared, alongside pulmonary function testing data and basic demographics.
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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.
David Mummy, PhD principal investigator
Duke University
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, run by Bastiaan Driehuys 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 9 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 20 Nov 2025. 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 David Mummy, PhD (9846847783, david.mummy@duke.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: 12 weeks). 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 20 Nov 2025.