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NCT02826343 · ClinicalTrials.gov registry record · Early Phase 1
New Technology to Assess Treatment for Chronic Obstructive Pulmonary Disease (COPD)
A Early Phase 1 study, sponsored by University of Virginia.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
NCT02826343 is a Early Phase 1 study that has completed, run by University of Virginia. The registered enrollment target is 30 participants.
The verdict
NCT02826343, a Early Phase 1 study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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. 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
Interventions
- DRUG Xenon129 MRI imaging
- DRUG Gadolinium MRI
- DRUG Advair (250mcg/50mcg) one puff twice a day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-05-01 |
| Est. Completion | 2018-06-15 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02826343
The ClinicalTrials.gov registry entry for NCT02826343 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Xenon129 MRI imaging is the first listed.
NCT02826343 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02826343 about?
NCT02826343 is a clinical study titled "New Technology to Assess Treatment for Chronic Obstructive Pulmonary Disease (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. T...
What is the current status of trial NCT02826343?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2016-05-01. Estimated completion is 2018-06-15.
What interventions are being tested in trial NCT02826343?
The interventions under investigation include: Xenon129 MRI imaging (DRUG), Gadolinium MRI (DRUG), Advair (250mcg/50mcg) one puff twice a day (DRUG).
Who is sponsoring clinical trial NCT02826343?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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