Clinical trial NCT03002389: Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics
Official title: Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
COPD
emphysema
MRI
hyper polarized gas MRI
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

* post bronchodilator PFT spirometry FEV1/FVC \< 70% predicted
* History of diagnosis of COPD
* History of alpha 1 anti-trypsin deficiency

Exclusion Criteria:

* previous diagnosis of asthma, interstitial lung disease, pulmonary vascular disease, inability to complete MRI or any of the assessment testings.

Primary outcomes:
measure: Changes in the hyper polarized MRI xenon-129 MRI (HXe MRI) assessment pre-post 30-day treatment of umeclidinium+vilanterol or Flovent
timeFrame: Time point with +/- 7 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67
Secondary outcomes:
measure: High resolution CT of lung
timeFrame: First baseline only=day 0
measure: Changes in pulmonary Function Test (PFT) from pre to post-umeclidinium+vilanterol or Flovent
timeFrame: Time point with +/- 7 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67
measure: Changes in Baseline Dyspnea Index from pre to post-umeclidinium+vilanterol or flovent
timeFrame: Time point with +/- 7 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67
measure: Changes in Transient Dyspnea Index from pre to post-umeclidinium+vilanterol or flovent
timeFrame: Time point with +/- 3 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67
measure: Changes in Saint George's Respiratory Questionnaire from pre to post-umeclidinium+vilanterol or flovent
timeFrame: Time point with +/- 3 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67
measure: Changes in Chronic Respiratory Questionnaire from pre to post-umeclidinium+vilanterol or flovent
timeFrame: Time point with +/- 3 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67
measure: Changes in BODE score from pre to post-umeclidinium+vilanterol or flovent
timeFrame: Time point with +/- 3 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67
measure: Changes in GOLD Stage from pre to post-umeclidinium+vilanterol or flovent
timeFrame: Time point with +/- 3 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67
Other outcomes:
Locations:
city: Keswick
country: United States
facility: Roselove NUNOO-ASARE
state: Virginia
Study officials:
affiliation: University of Virginia
name: Yun M Shim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Kun Qing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qing K, Ruppert K, Jiang Y, Mata JF, Miller GW, Shim YM, Wang C, Ruset IC, Hersman FW, Altes TA, Mugler JP 3rd. Regional mapping of gas uptake by blood and tissue in the human lung using hyperpolarized xenon-129 MRI. J Magn Reson Imaging. 2014 Feb;39(2):346-59. doi: 10.1002/jmri.24181. Epub 2013 May 16.
citation: Qing K, Mugler JP 3rd, Altes TA, Jiang Y, Mata JF, Miller GW, Ruset IC, Hersman FW, Ruppert K. Assessment of lung function in asthma and COPD using hyperpolarized 129Xe chemical shift saturation recovery spectroscopy and dissolved-phase MRI. NMR Biomed. 2014 Dec;27(12):1490-501. doi: 10.1002/nbm.3179. Epub 2014 Aug 22.