Evaluating lung function in severe asthma patients with mucus plugs
Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Severe Asthma
This study is testing how mucus plugs in the lungs affect breathing and airflow in people with severe asthma using special imaging techniques.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Drugs / interventions | dupilumab, tezepelumab, benralizumab |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT06985225 on ClinicalTrials.gov |
What this trial studies
This observational study uses xenon MRI to assess the impact of mucus plugs on lung ventilation and gas exchange in patients with severe asthma. Mucus plugs will be identified through CT imaging, and the study aims to evaluate the regional functional consequences of these plugs on lung function. Participants will undergo imaging to determine how these obstructions affect airflow and overall respiratory health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a physician diagnosis of asthma for over a year and specific blood eosinophil and FeNO levels.
Not a fit: Patients with significant concomitant medical illnesses or recent respiratory infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of severe asthma by identifying specific ventilation defects caused by mucus plugs.
How similar studies have performed: While the use of xenon MRI in this context is relatively novel, similar imaging techniques have shown promise in evaluating lung function in other respiratory conditions.
Eligibility criteria
Show full inclusion / exclusion 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. * 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.
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: Cristal Monge
- Email: chernandez@kumc.edu
- Phone: (913) 945-9399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.