RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06985225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Cristal Monge

CONTACT

(913) 945-9399

chernandez@kumc.edu

Study Locations (Sites)

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-06

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Xenon MRI
Mucus Plug
Severe Asthma

Additional Relevant MeSH Terms

Severe Asthma