Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Severe Asthma

Recruiting

• Conditions: Severe Asthma

• Registration Number: NCT06985225
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Study Start: 2025-06
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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.
• Blood eosinophil count > 300 cells/μL and FeNO >25ppb
• Smoking history <10 pack years
• No smoking history (including vapes, cigar, or marijuana use) in the last 3 months
• Approved for 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
• 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 canula
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventilation Defect in Mucus blocked Regions	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 Outcome Measures

Name	Time	Method
Change in VDP	4-weeks	1) The change in VDP downstream of mucus plugs 4-weeks following initiation of biologic therapy.
Long term change in VDP	12-weeks	The change in VDP downstream of mucus plugs 12-weeks following initiation of biologic therapy.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States