Downstream Effects of Airway Mucus Plugs on 129Xenon MRI... | NCT07139899

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

NCT07139899

Sponsor

Bastiaan Driehuys

Status

Recruiting

Last Update Posted

Nov 20, 2025Actual

Enrollment

5Estimated

Phase

Not provided

Conditions

Severe Asthma

Interventions

Hyperpolarized Xenon 129

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 17, 2025Actual

Primary Completion Date

Nov 2026Estimated

Completion Date

Sep 2027Estimated

First Submitted Date

Aug 18, 2025

First Submission Date that Met QC Criteria

Aug 18, 2025

First Posted Date

Aug 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2025

Last Update Posted Date

Nov 20, 2025Actual

Name	Class
University of Kansas Medical Center	OTHER
Polarean, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Name	Type	Description	Arm Group Labels	Other Names
Hyperpolarized Xenon 129	Combination Product	Pulmonary magnetic resonance imaging using hyperpolarized xenon-129 gas as an inhaled contrast agent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ventilation Defect in Mucus-blocked regions	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).	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in VDP	The change in VDP downstream of mucus plugs 4 weeks following initiation of biologic therapy.	4 weeks
Long term change in VDP	Change in VDP downstream of mucus plugs 12 weeks following initiation of biologic therapy

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with High T2 Severe Asthma

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
David Mummy, PhD	Contact	9846847783		david.mummy@duke.edu
Bastiaan Driehuys, PhD	Contact	919-684-7786		bastiaan.driehuys@duke.edu

Name	Affiliation	Role
David Mummy, PhD	Duke University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center	Recruiting	Durham	North Carolina	27713	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Images from participants will be shared, alongside pulmonary function testing data and basic demographics.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases