NCT03002389

Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Hyper polarized xenon-129 MRI (HXe MRI) is a unique imaging test which can detect how air is flowing in and out of lungs and how oxygen can move from inhaled air into the blood. Chronic Obstructive Pulmonary Disease (COPD) is a disease in which patients develop narrowing of airways, thus, having difficulties breathing air in and out their lungs and also damaging the lung tissues which patients need to move oxygen from the air into blood. In this study, two drugs which are already approved by FDA (Anoro and Arnuity) will be administered to patients who are already known to have COPD. While patients are being treated with these two drugs (one drug at a time over a month), lung health by using usual testing methods (CT scan of the lung, pulmonary function test, and blood test) will be assessed in addition to HXe MRI. The goal of this study is to prove that the HXe MRI is an excellent imaging test to show the state of lung health among COPD patients and also to obtain new informations on how lung health changes with drugs that are already approved by US FDA. This work is anticipated to help develop HXe MRI as a new clinical test which can guide how to treat patients with COPD and if new therapies can improve lung health of patients with COPD.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Anoro Ellipta	inhaler approved by FDA (strength umeclidinium 65 microgram + vilanterol 25 microgram) One puff once a day for 30 days
DRUG	Arnuity Ellipta	inhaler approved by FDA (strength 250 microgram) One puff twice a day for 30 days

Timeline

• Start date: 2017-11-05
• Primary completion: 2023-12-31
• Completion: 2028-01-31
• First posted: 2016-12-23
• Last updated: 2024-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study