Anoro + Arnuity for COPD

Overseen By Roselove M Asare

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Virginia

Must be taking: Anoro, Arnuity

Disqualifiers: Asthma, Interstitial lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 63 days

95 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kun Qing, PhD

Principal Investigator

University of Virginia

Yun M Shim, MD

Principal Investigator

University of Virginia

Eligibility Criteria

This trial is for adults with COPD, a lung condition that makes it hard to breathe. Participants must have specific breathing test results (FEV1/FVC < 70%) and may have alpha-1 antitrypsin deficiency. It's not for those with asthma, interstitial lung disease, pulmonary vascular disease or who can't undergo MRI or other tests.

Inclusion Criteria

Your lung function test shows that your breathing is not strong enough.

I have been diagnosed with COPD.

Your lung function test shows a specific measurement that is less than 70% of what is expected.

Exclusion Criteria

I have been diagnosed with interstitial lung disease before.

I have been diagnosed with a lung blood vessel condition before.

I have been diagnosed with asthma before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Anoro for 30 days, followed by a 3-day washout, then Arnuity for 30 days

63 days

Multiple visits for drug administration and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Anoro Ellipta
• Arnuity Ellipta
• Hyperpolarized Xenon-129 MRI

Trial Overview The study tests how well two FDA-approved drugs, Anoro Ellipta and Arnuity Ellipta, improve lung health in COPD patients using traditional methods plus a new type of MRI called Hyperpolarized Xenon-129 MRI. This aims to establish HXe MRI as a tool for assessing treatment effectiveness.

Participant Groups

Group I: All COPD Subjects Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+