Health TrialsbyHealthPanel

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

ConditionSevere Asthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorBastiaan Driehuys

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with High T2 Severe Asthma

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Hyperpolarized Xenon 129

    Combination product

    Pulmonary magnetic resonance imaging using hyperpolarized xenon-129 gas as an inhaled contrast agent

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
12 weeks

Secondary outcomes

1

Change in VDP

The change in VDP downstream of mucus plugs 4 weeks following initiation of biologic therapy.

Time frame
4 weeks
2

Long term change in VDP

Change in VDP downstream of mucus plugs 12 weeks following initiation of biologic therapy

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bastiaan Driehuys

Lead sponsor

Duke University

Sponsor institution

University of Kansas Medical Center

Collaborator

Polarean, Inc.

Collaborator

Source ClinicalTrials.gov
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