Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics
NCT ID: NCT03002389
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
95 participants
INTERVENTIONAL
2017-11-05
2028-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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All COPD Subjects
All subjects will be assessed with hyper polarized xenon-129 MRI, pulmonary function test, quality of life measures (BDI, TDI, SGRQ, CRQ, BODE, GOLD), and blood test.
Intervention: All subjects will received Anoro one puff once a day for 30 days first, then 3 day washout, then Arnuity 250 microgram one puff twice a day for 30 days to complete the study.
Anoro Ellipta
inhaler approved by FDA (strength umeclidinium 65 microgram + vilanterol 25 microgram) One puff once a day for 30 days
Arnuity Ellipta
inhaler approved by FDA (strength 250 microgram) One puff twice a day for 30 days
Interventions
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Anoro Ellipta
inhaler approved by FDA (strength umeclidinium 65 microgram + vilanterol 25 microgram) One puff once a day for 30 days
Arnuity Ellipta
inhaler approved by FDA (strength 250 microgram) One puff twice a day for 30 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of diagnosis of COPD
* History of alpha 1 anti-trypsin deficiency
Exclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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Y. Michael Shim, MD
Assoicate Professor, Department of Medicine
Principal Investigators
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Yun M Shim, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Kun Qing, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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Roselove NUNOO-ASARE
Keswick, Virginia, United States
Countries
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References
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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.
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.
Other Identifiers
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19569-19352
Identifier Type: -
Identifier Source: org_study_id
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