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NCT03002389 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Chronic Obstructive Pulmonary Disease, sponsored by University of Virginia.

Active
Registry status
Phase 2
Development phase
95
Enrollment target
1
Study location

NCT03002389 is a Phase 2 study of Chronic Obstructive Pulmonary Disease that is active but no longer recruiting, run by University of Virginia. The registered enrollment target is 95 participants, below the 1,753-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03002389, a Phase 2 study of Chronic Obstructive Pulmonary Disease, is active but no longer recruiting, sponsored by University of Virginia.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
95 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG Anoro Ellipta
  • DRUG Arnuity Ellipta

Study Locations (1)

Virginia

  • Roselove NUNOO-ASARE - Keswick

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2017-11-05
Est. Completion 2028-01-31
Phase Phase 2

Sponsor

University of Virginia

449 total trials

What the Registry Record Tells You About NCT03002389

The ClinicalTrials.gov registry entry for NCT03002389 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,753-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (95% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 2 interventions - of which Anoro Ellipta is the first listed.

NCT03002389 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT03002389 about?

NCT03002389 is a clinical study titled "Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics". 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 dif...

What is the current status of trial NCT03002389?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2017-11-05. Estimated completion is 2028-01-31.

What conditions does trial NCT03002389 study?

This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease.

What interventions are being tested in trial NCT03002389?

The interventions under investigation include: Anoro Ellipta (DRUG), Arnuity Ellipta (DRUG).

Who is sponsoring clinical trial NCT03002389?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03002389 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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