drugset / Trial / NCT03002389

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

NCT03002389

Phase 2 Active not recruiting 95 enrolled University of Virginia
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2017-11-05
Primary completion
2023-12-31
Completion
2028-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone Other / unclassified 250 ug Inhaled
Subject Umeclidinium Other / unclassified 65 ug Inhaled
Subject Vilanterol Other / unclassified 25 ug Inhaled