Downstream Effects of Airway Mucus Plugs on 129Xenon MRI in Severe Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperpolarized Xenon 129.
- Who it may be relevant to
- Registry conditions: Severe Asthma. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Downstream Effects of Airway Mucus Plugs on 129Xenon MRI Following Biologic Therapy
Overview
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.
Interventions
- Combination product Hyperpolarized Xenon 129
Pulmonary magnetic resonance imaging using hyperpolarized xenon-129 gas as an inhaled contrast agent
Primary outcome measures
- Ventilation Defect in Mucus-blocked regions [Time frame: 12 weeks]
Secondary outcome measures (2)
- Change in VDP [Time frame: 4 weeks]
- Long term change in VDP [Time frame: 12 weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Duke University Medical Center — Durham
Identifiers
NCT: NCT07139899 · Pro00117680