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NCT Number: NCT07139899

Downstream Effects of Airway Mucus Plugs on 129Xenon MRI in Severe Asthma

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27713, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperpolarized Xenon 129

Combination Product

Pulmonary magnetic resonance imaging using hyperpolarized xenon-129 gas as an inhaled contrast agent

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in VDP

    Time frame: 4 weeks

    The change in VDP downstream of mucus plugs 4 weeks following initiation of biologic therapy.

  2. Long term change in VDP

    Time frame: 12 weeks

    Change in VDP downstream of mucus plugs 12 weeks following initiation of biologic therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Bastiaan Driehuys, PhD

CONTACT

[email protected]

919-684-7786

David Mummy, PhD

CONTACT

[email protected]

9846847783

Sponsors and collaborators

Lead sponsor

Bastiaan Driehuys

Other

Collaborators

  • Polarean, Inc.
  • University of Kansas Medical Center

Registry information

Official study title

Downstream Effects of Airway Mucus Plugs on 129Xenon MRI Following Biologic Therapy

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 24, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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