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Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Muco-Obstructive Lung Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with muco-obstructive pulmonary disease."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses CT scans to find mucus plugs in the lungs and xenon MRI scans to see how they affect breathing. It looks at how air and gases move in lung areas beyond these plugs. It is for adults ages 18–65 with a lung disease that causes mucus to block airways.

In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with muco-obstructive pulmonary disease. 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Complete the informed consent process and sign a form agreeing to join.
  • Be 18–65 years old.
  • Have a doctor-diagnosed mucus-blocking lung disease for more than 1 year: cystic fibrosis, severe asthma, COPD, or bronchiectasis not caused by cystic fibrosis. Bronchiectasis means damaged, widened airways.
  • Be able to repeat a breathing test called spirometry with consistent results that meet testing standards.

Who can't join

  • Have a breathing tract infection or a lung-related emergency room visit within 4 weeks before the first visit.
  • Have a body mass index (BMI), a measure based on height and weight, above 30 at the first visit.
  • Have not waited 4 weeks before the first visit after a one-time dose, such as an injection into a joint.
  • Have another serious illness, such as heart disease, cancer, uncontrolled diabetes, or another long-term lung disease, as judged by the study doctor.
  • Have an oxygen level below 90% while resting, even with the most extra oxygen given through a nose tube.
  • Have a positive urine pregnancy test.
  • Have joined a study testing a treatment or procedure, including a scope exam of the airways, or used an experimental drug in the past 30 days; or plan to join such a study during this study.
  • Cannot safely have an MRI, or the study doctor believes you cannot or likely will not finish the study tests, or that the study poses too much risk.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Adequate completion of informed consent process with written documentation * Patients 18 - 65 years old * • Physician diagnosis of muco-obstructive pulmonary disease, including cystic fibrosis, severe asthma, chronic obstructive pulmonary disease, or non-cystic fibrosis bronchiectasis for \> 1 year * Able to perform reproducible spirometry according to ATS criteria based on clinical PFTs. 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 * ER visit related to pulmonary condition 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 * 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 sites (1)

KS