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

NCT03002389 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 19569-19352
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease; COPD; emphysema; MRI; hyper polarized gas MRI

Outcome Measures

Primary Outcomes (1)

• Changes in the hyper polarized MRI xenon-129 MRI (HXe MRI) assessment pre-post 30-day treatment of umeclidinium+vilanterol or Flovent

  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.

  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 (8)

• High resolution CT of lung

  First baseline only=day 0

• Changes in pulmonary Function Test (PFT) from pre to post-umeclidinium+vilanterol or Flovent

  Time point with +/- 7 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67

• Changes in Baseline Dyspnea Index from pre to post-umeclidinium+vilanterol or flovent

  Time point with +/- 7 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67

• Changes in Transient Dyspnea Index from pre to post-umeclidinium+vilanterol or flovent

  Time point with +/- 3 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67

• Changes in Saint George's Respiratory Questionnaire from pre to post-umeclidinium+vilanterol or flovent

  Time point with +/- 3 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67

Study Arms (1)

All COPD Subjects

OTHER

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; Drug: Arnuity Ellipta

Interventions

Anoro Ellipta DRUG

inhaler approved by FDA (strength umeclidinium 65 microgram + vilanterol 25 microgram) One puff once a day for 30 days

Also known as: umeclidinium + vilanterol

All COPD Subjects

Arnuity Ellipta DRUG

inhaler approved by FDA (strength 250 microgram) One puff twice a day for 30 days

Also known as: fluticasone

All COPD Subjects

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

Roselove NUNOO-ASARE

Keswick, Virginia, 22947, United States

Location

Related Publications (2)

• 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.

  PMID: 23681559 RESULT

• 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.

  PMID: 25146558 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Interventions

GSK573719; vilanterol; Fluticasone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yun M Shim, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Kun Qing, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoicate Professor, Department of Medicine

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 23, 2016
• Study Start: November 5, 2017
• Primary Completion: December 31, 2023
• Study Completion (Estimated): January 31, 2028
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

US (1)