How airway mucus plugs affect ventilation and gas exchange on 129Xe MRI in severe asthma
Downstream Effects of Airway Mucus Plugs on 129Xenon MRI Following Biologic Therapy
This project will use hyperpolarized 129Xe MRI to see if mucus plugs cause local airflow and gas-exchange problems in adults with severe asthma who are starting certain biologic medicines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | dupilumab, tezepelumab, benralizumab |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT07139899 on ClinicalTrials.gov |
What this trial studies
This is an observational imaging study using CT to identify airway mucus plugs and hyperpolarized 129Xe MRI to map ventilation and gas exchange in the lung regions downstream from those plugs. Participants are adults with severe asthma, blood eosinophils >300 cells/µL, limited smoking history, and about to begin standard-of-care biologic therapy such as dupilumab, tezepelumab, or benralizumab. Spirometry reproducible by ATS criteria is required and recent respiratory infection or very high BMI are exclusion criteria. Imaging will compare CT-defined plug locations with regional ventilation and gas-exchange abnormalities on 129Xe MRI to characterize functional consequences of plugs.
Who should consider this trial
Good fit: Adults 18–65 with physician-diagnosed severe asthma for >1 year, blood eosinophils >300 cells/µL, <10 pack-year smoking history, able to perform reproducible spirometry, and about to start dupilumab, tezepelumab, or benralizumab are the intended participants.
Not a fit: People with mild asthma, BMI over 30, recent respiratory infection, substantial recent smoking, or those not starting the specified biologics are unlikely to benefit from this imaging-focused study.
Why it matters
Potential benefit: If successful, this work could help clinicians pinpoint how mucus plugs impair local lung function and guide monitoring or targeted treatments.
How similar studies have performed: Prior work using hyperpolarized gas MRI and CT in obstructive lung disease has shown feasibility and useful physiologic insights, but combining CT-identified mucus plugs with downstream 129Xe gas-exchange mapping is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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.
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: David Mummy, PhD — Duke University
- Study coordinator: David Mummy, PhD
- Email: david.mummy@duke.edu
- Phone: 9846847783
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.