Downstream Effects of Airway Mucus Plugs on 129Xenon MRI in Severe Asthma
Recruiting · NCT07139899 · Observational (researchers observe without assigning treatment) · Lead sponsor: Bastiaan Driehuys
View the official record on ClinicalTrials.gov →Interventions studied
Hyperpolarized Xenon 129
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
1 location listed across 1 US state.
- Duke University Medical Center - Durham, North Carolina, United States