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Trial record 36 of 101 for:    Emphysema | Recruiting, Not yet recruiting, Available Studies | "Lung Diseases"

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

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ClinicalTrials.gov Identifier: NCT03002389
Recruitment Status : Recruiting
First Posted : December 23, 2016
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Y. Michael Shim, MD, University of Virginia

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Anoro Ellipta Drug: Arnuity Ellipta Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics
Estimated Study Start Date : November 5, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Drug: Anoro Ellipta
inhaler approved by FDA (strength umeclidinium 65 microgram + vilanterol 25 microgram) One puff once a day for 30 days
Other Name: umeclidinium + vilanterol

Drug: Arnuity Ellipta
inhaler approved by FDA (strength 250 microgram) One puff twice a day for 30 days
Other Name: fluticasone




Primary Outcome Measures :
  1. Changes in the hyper polarized MRI xenon-129 MRI (HXe MRI) assessment pre-post 30-day treatment of umeclidinium+vilanterol or Flovent [ Time Frame: Time point with +/- 7 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67 ]

    In vivo lung physiology measurement obtained by HXe MRI pre and post drug intervention.

    In vivo lung physiology is measured by % of the lung that does not ventilate (dead space ventilation), among of the dissolved xenon-129 gas location among airways, interstitial tissues, or circulating red blood cells. These measures will be reported as continuous variables for data analyses.



Secondary Outcome Measures :
  1. High resolution CT of lung [ Time Frame: First baseline only=day 0 ]

    Quantification of emphysematous lung tissues and abnormally thickened airways in correlation with changed detectable by HXe MRI.

    % of lung tissues with emphysema will be quantified by measuring tissue density using Hounsfield Unit (HU). Based on COPDgene and other studies, we will use HU < -950 as emphysematous lung tissue. The lung CT scan will then be processed to yield % of lung tissue with emphysema. The airway thickness will be measured by standardized imaging algorithm developed by VIDA imaging.


  2. Changes in pulmonary Function Test (PFT) from pre to post-umeclidinium+vilanterol or Flovent [ Time Frame: Time point with +/- 7 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67 ]

    Measurement of in vivo lung physiology using clinical standard testing in correlation with HXe MRI changes pre and post drug intervention.

    The gas exchange capacity will be assessed by diffusion capacity of carbon monoxide represented as percent DLCO. This is a standard clinical measure being used routinely in pulmonary clinics.


  3. Changes in Baseline Dyspnea Index from pre to post-umeclidinium+vilanterol or flovent [ Time Frame: Time point with +/- 7 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67 ]

    Measurement of in vivo lung physiology using clinical standard quality of life testing in correlation with HXe MRI changes pre and post drug intervention.

    Quality of life survey will be administered to obtain numeric number as a results.


  4. Changes in Transient Dyspnea Index from pre to post-umeclidinium+vilanterol or flovent [ Time Frame: Time point with +/- 3 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67 ]

    Measurement of in vivo lung physiology using clinical standard quality of life testing in correlation with HXe MRI changes pre and post drug intervention.

    Quality of life survey will be administered to obtain numeric number as a results.


  5. Changes in Saint George's Respiratory Questionnaire from pre to post-umeclidinium+vilanterol or flovent [ Time Frame: Time point with +/- 3 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67 ]

    Measurement of in vivo lung physiology using clinical standard quality of life testing in correlation with HXe MRI changes pre and post drug intervention.

    Quality of life survey will be administered to obtain numeric number as a results.


  6. Changes in Chronic Respiratory Questionnaire from pre to post-umeclidinium+vilanterol or flovent [ Time Frame: Time point with +/- 3 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67 ]

    Measurement of in vivo lung physiology using clinical standard quality of life testing in correlation with HXe MRI changes pre and post drug intervention.

    Quality of life survey will be administered to obtain numeric number as a results.


  7. Changes in BODE score from pre to post-umeclidinium+vilanterol or flovent [ Time Frame: Time point with +/- 3 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67 ]
    Measurement of in vivo lung physiology and mortality prediction score using clinical standard testing in correlation with HXe MRI changes pre and post drug intervention. BODE score is calculated by the results from the pulmonary function test, modified medical research council score, and body mass index. This will yield a score ranging from 0 to 10 with higher scores predicting higher chance of mortality.

  8. Changes in GOLD Stage from pre to post-umeclidinium+vilanterol or flovent [ Time Frame: Time point with +/- 3 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67 ]

    Measurement of in vivo lung physiology and mortality prediction score using clinical standard testing in correlation with HXe MRI changes pre and post drug intervention.

    GOLD stage is calculated by a combination of pulmonary function test result, modified medical research council score, and history of frequency of COPD exacerbation previous 12 months. This score will yield GOLD stages A (mild) to , B, C, D (most severe).




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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002389


Contacts
Contact: Rachel Dieterich, RN 4342436074 rrd8w@virginia.edu
Contact: Yun M Shim, MD 4349245210 yss6n@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Rachel Dieterich, R.N.    434-243-6074    rrd8w@virginia.edu   
Contact: Yun M Shim, M.D.    434-924-5210    yss6n@virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Yun M Shim, MD University of Virginia
Principal Investigator: Kun Qing, PhD University of Virginia

Publications of Results:
Responsible Party: Y. Michael Shim, MD, Assoicate Professor, Department of Medicine, University of Virginia
ClinicalTrials.gov Identifier: NCT03002389     History of Changes
Other Study ID Numbers: 19352
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: At the conclusion of the study, correlation data between COPD phenotypes and changes in MRI characteristics will be shared. Data from individuals will be complied with unique study-generated subject ID after removing all personal identifiers. Once this is completed, the data may be shared with hyper polarized MR imaging network currently being formed in collaboration with University of WI, U Penn, Duke, U of Cincinnati, and U Missouri. The data will be accessible by these investigators after the data sharing plans are reviewed by the IRB of the record (at the University of Virginia).

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Y. Michael Shim, MD, University of Virginia:
chronic obstructive pulmonary disease
COPD
emphysema
MRI
hyper polarized gas MRI

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Xenon
Coal Tar
Fluticasone
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Allergic Agents