How airway mucus plugs affect ventilation and gas exchange on 129Xe MRI in severe asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.