Pulmonary Disease, Chronic ObstructiveEarly Phase 1NCT02826343
New Technology to Assess Treatment for Chronic Obstructive Pulmonary Disease (COPD)
A Early Phase 1 study testing Xenon129 MRI imaging, Gadolinium MRI and Advair (250mcg/50mcg) one puff twice a day in people with Pulmonary Disease, Chronic Obstructive, run by University of Virginia at 1 site in United States.
Trial summary
First, the investigators will image patients with hyperpolarized xenon (Xe) magnetic resonance imaging (MRI) to develop the technique of hyperpolarized xenon MRI at the University of Virginia (UVA). Magnetic Resonance (MR) sequences will need to be developed and optimized for the equipment at UVA. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Xenon129 MRI imaging, Gadolinium MRI and Advair (250mcg/50mcg) one puff twice a day
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2016to 15 Jun 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects should be at their clinical baseline on the day of imaging
- Subjects must be clinically stable in order to participate in the study
- Smoking history >10 pack years
- Subjects must not be currently taking Advair or have taken it within 4 weeks prior to screening
- No subject will be withdrawn from Advair to participate in this study
- The subjects with COPD will be categorized according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD severity classification:
Show all 10Show fewer
- Class 1: forced expiratory volume at one second (FEV1)/forced vital capacity (FVC) < 70 and FEV1 > 80% predicted;
- Class 2: FEV1/FVC < 70 and 50% < FEV1 < 80% predicted;
- Class 3: FEV1/FVC < 70 and 30% < FEV1 < 50% predicted;
- Class 4: FEV1/FVC < 70 and FEV1 < 30% predicted
Who cannot join
- Continuous oxygen use at home
- Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of imaging
- FEV1 percent predicted less than 25%
- Pregnancy or lactation
- Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning
- Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
Show all 17Show fewer
- Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches.
- History of congenital cardiac disease, chronic renal failure, or cirrhosis.
- Inability to understand simple instructions or to hold still for approximately 10 seconds.
- History of respiratory infection within 2 weeks prior to the MR scan
- History of myocardial infarction (MI) , stroke and/or poorly controlled hypertension.
- Known hypersensitivity to albuterol or any of its components, or levalbuterol
- Glomerular filtration rate (GFR) < 60 ml/min/1.73 m2 or known hypersensitivity to Gd-contrast agents based on a serum creatinine drawn within 30 days of the MRI
- Acute kidney injury
- History of paraproteinemia syndromes such as multiple myeloma
- Hepatorenal syndrome
- Liver transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Xe129 Magnetic Resonance Imaging of the Lung: A New Technology to Assess Treatment for COPD
First, the investigators will image patients with hyperpolarized xenon (Xe) magnetic resonance imaging (MRI) to develop the technique of hyperpolarized xenon MRI at the University of Virginia (UVA). Magnetic Resonance (MR) sequences will need to be developed and optimized for the equipment at UVA. These sequences will need to be evaluated in healthy adults for comparison with results obtained and in adults with lung diseases to optimize the sequences for the detection and evaluation of lung diseases. The MR pulse sequences need to be optimized for the parameters of a human MR coil and the gas exchange characteristics in healthy and diseased lungs.
Second, the investigators propose to exploit the power of Xe129 MRI as a diagnostic tool to monitor therapeutic responses of a combination inhaler, Advair, which contains a long-acting beta-adrenoceptor agonist (LABA) and an inhaled corticosteroid (ICS) - two major classes of the current COPD therapeutics. The investigators will characterize the functional changes of the lungs with COPD at baseline, and investigate the responses of the lungs to the treatment after a three-month trial. Also the investigators will compare corresponding results obtained by Xe129 dissolved phase (DP) MRI to the results obtained by gadolinium-based dynamic contrast-enhanced perfusion MRI (perfusion MRI) and high resolution computed tomography (HRCT) of the lung to indirectly validate the Xe129 DP MRI technique. The investigators anticipate that the results from this project will greatly improve the investigators understanding of the lung functional responses of COPD subjects to current therapeutics. Also, the investigators expect that this project will provide evidence to consider Xe129 MRI as a diagnostic strategy to assess and monitor therapeutic responses of existing and new pharmaceuticals, and thus Xe129 MRI will stimulate development of novel therapies for COPD in the future
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Xenon129 MRI imaging, Gadolinium MRI, Advair (250mcg/50mcg) one puff twice a day
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenon129 MRI imagingDrug
subjects will receive at baseline and 3 month post Advair intervention (See next intervention)
Gadolinium MRIDrug
subjects will receive at baseline and 3 month post Advair intervention (See next intervention)
Advair (250mcg/50mcg) one puff twice a dayDrug
subjects will receive for 3 month duration between baseline and 3 month post Xenon129 MRI imaging and Gadolinium MRI.
| Study group | Role | What they receive |
|---|---|---|
| COPD Advair | Other | Subjects will undergo hyperpolarized xenon MRI with perfusion imaging, before and after a 90 day course of Adair.
All subjects belong to one arm and will receive same treatment. Then they are compared at baseline and 3 month post intervention (described below) for within same-subject changes.
Subjects will be administered with
1. Hyperpolarized Xenon129 inhalation during MRI twice (at baseline and post 3 month Advair)
2. Gadolinium intravenous contrast during MRI twice (at baseline and post 3 month Advair)
3. Advair diskus: strength 250mcg/50mcg, one puff twice a day for 3 months. Receives: Drug: Xenon129 MRI imaging; Drug: Gadolinium MRI; Drug: Advair (250mcg/50mcg) one puff twice a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pulmonary airflow physiology detected by Xenon129 MRI
MRI will determine anticipated improvement in patients' airflow limitation correlation ventilation defect.
Measured: From baseline to 3 month post treatment with Advair
Improvement in pulmonary gas exchange physiology detected by Xenon129 MRI
Dissolved phase Xe129 of the MRI will determine anticipated improvement in patients' gas exchange capacity in lung tissues correlating with tissue damage caused by COPD.
Measured: From baseline to 3 month post treatment with Advair
Secondary outcomes (7)
Improvement in clinical pulmonary function test
Pulmonary function test will measure anticipated improvement in patients lung function after using Advair.
Measured: From baseline to 3 month post treatment with Advair
St. George's Respiratory Questionnaire
St. George's Respiratory Questionnaire will measure anticipated improvement in subjective symptoms of patients.
Measured: From baseline to 3 month post treatment with Advair
Baseline Dyspnea Index
Baseline Dyspnea Index will measure anticipated improvement in subjective symptoms of patients.
Measured: From baseline to 3 month post treatment with Advair
Transition Dyspnea Index
Transition Dyspnea Index will measure anticipated improvement in subjective symptoms of patients.
Measured: From baseline to 3 month post treatment with Advair
Chronic Respiratory Questionnaire
Chronic Respiratory Questionnaire will measure anticipated improvement in subjective symptoms of patients.
Measured: From baseline to 3 month post treatment with Advair
BODE score
BODE score will measure anticipated improvement in subjective symptoms of patients.
Measured: From baseline to 3 month post treatment with Advair
GOLD Stage
GOLD Stage will measure anticipated improvement in subjective symptoms of patients.
Measured: From baseline to 3 month post treatment with Advair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start1 May 2016
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Y. Michael Shim, MD, University of Virginia
- Investigators
- Y Michael Shim, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826343
- Sponsor's protocol ID
- 18667
- Status last verified
- Nov 2020
- First submitted
- 10 May 2016
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xe129 Magnetic Resonance Imaging of the Lung: A New Technology to Assess Treatment for COPD
- ClinicalTrials.gov ID
- NCT02826343
- Acronym / sponsor ID
- 18667
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 May 2016 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First, the investigators will image patients with hyperpolarized xenon (Xe) magnetic resonance imaging (MRI) to develop the technique of hyperpolarized xenon MRI at the University of Virginia (UVA). Magnetic Resonance (MR) sequences will need to be developed and optimized for the equipment at UVA. These sequences will need to be evaluated in healthy adults for comparison with results obtained and in adults with lung diseases to optimize the sequences for the detection and evaluation of lung diseases. The MR pulse sequences need to be optimized for the parameters of a human MR coil and the gas exchange characteristics in healthy and diseased lungs.
Second, the investigators propose to exploit the power of Xe129 MRI as a diagnostic tool to monitor therapeutic responses of a combination inhaler, Advair, which contains a long-acting beta-adrenoceptor agonist (LABA) and an inhaled corticosteroid (ICS) - two major classes of the current COPD therapeutics. The investigators will characterize the functional changes of the lungs with COPD at baseline, and investigate the responses of the lungs to the treatment after a three-month trial. Also the investigators will compare corresponding results obtained by Xe129 dissolved phase (DP) MRI to the results obtained by gadolinium-based dynamic contrast-enhanced perfusion MRI (perfusion MRI) and high resolution computed tomography (HRCT) of the lung to indirectly validate the Xe129 DP MRI technique. The investigators anticipate that the results from this project will greatly improve the investigators understanding of the lung functional responses of COPD subjects to current therapeutics. Also, the investigators expect that this project will provide evidence to consider Xe129 MRI as a diagnostic strategy to assess and monitor therapeutic responses of existing and new pharmaceuticals, and thus Xe129 MRI will stimulate development of novel therapies for COPD in the future
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD Advair | Other | Drug: Xenon129 MRI imaging, Drug: Gadolinium MRI, Drug: Advair (250mcg/50mcg) one puff twice a daySubjects will undergo hyperpolarized xenon MRI with perfusion imaging, before and after a 90 day course of Adair. All subjects belong to one arm and will receive same treatment. Then they are compared at baseline and 3 month post intervention (described below) for within same-subject changes. Subjects will be administered with 1. Hyperpolarized Xenon129 inhalation during MRI twice (at baseline and post 3 month Advair) 2. Gadolinium intravenous contrast during MRI twice (at baseline and post 3 month Advair) 3. Advair diskus: strength 250mcg/50mcg, one puff twice a day for 3 months. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects should be at their clinical baseline on the day of imaging
- Subjects must be clinically stable in order to participate in the study
- Smoking history >10 pack years
- Subjects must not be currently taking Advair or have taken it within 4 weeks prior to screening
- No subject will be withdrawn from Advair to participate in this study
Key exclusion criteria (17 listed)
- Continuous oxygen use at home
- Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of imaging
- FEV1 percent predicted less than 25%
- Pregnancy or lactation
- Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xenon129 MRI imagingsubjects will receive at baseline and 3 month post Advair intervention (See next intervention) | Drug | COPD Advair |
| Gadolinium MRIsubjects will receive at baseline and 3 month post Advair intervention (See next intervention) | Drug | COPD Advair |
| Advair (250mcg/50mcg) one puff twice a daysubjects will receive for 3 month duration between baseline and 3 month post Xenon129 MRI imaging and Gadolinium MRI. | Drug | COPD Advair |
Primary outcome
Improvement in pulmonary airflow physiology detected by Xenon129 MRI
Time frame: From baseline to 3 month post treatment with Advair
MRI will determine anticipated improvement in patients' airflow limitation correlation ventilation defect.
Improvement in pulmonary gas exchange physiology detected by Xenon129 MRI
Time frame: From baseline to 3 month post treatment with Advair
Dissolved phase Xe129 of the MRI will determine anticipated improvement in patients' gas exchange capacity in lung tissues correlating with tissue damage caused by COPD.
7 secondary outcomes
Improvement in clinical pulmonary function test
Time frame: From baseline to 3 month post treatment with Advair
St. George's Respiratory Questionnaire
Time frame: From baseline to 3 month post treatment with Advair
Baseline Dyspnea Index
Time frame: From baseline to 3 month post treatment with Advair
Transition Dyspnea Index
Time frame: From baseline to 3 month post treatment with Advair
Chronic Respiratory Questionnaire
Time frame: From baseline to 3 month post treatment with Advair
BODE score
Time frame: From baseline to 3 month post treatment with Advair
GOLD Stage
Time frame: From baseline to 3 month post treatment with Advair
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Y Michael Shim, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Xenon129 MRI imaging, Gadolinium MRI and Advair (250mcg/50mcg) one puff twice a day in people with Pulmonary Disease, Chronic Obstructive, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in pulmonary airflow physiology detected by Xenon129 MRI (time frame: From baseline to 3 month post treatment with Advair). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.