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Bronchodilator

Anoro + Arnuity for COPD

Phase 2

Recruiting

Led By Yun M Shim, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of diagnosis of COPD

History of alpha 1 anti-trypsin deficiency

Must not have

Previous diagnosis of interstitial lung disease

Previous diagnosis of pulmonary vascular disease

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess the effects of two drugs on COPD patients using MRI to detect how air is flowing in and out of lungs and how oxygen can move from inhaled air into the blood.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects are not detailed here, Anoro and Arnuity typically might cause throat irritation, coughing, headaches or increased risk of infections. The HXe MRI is non-invasive but requires inhaling xenon gas; risks are minimal but could include discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with COPD.

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I have a history of alpha 1 anti-trypsin deficiency.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with interstitial lung disease before.

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

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I have been diagnosed with asthma before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and time point with +/- 7 day window: first baseline=day 0, first follow-up=day 30, second baseline=day 37, second follow-up=day 67 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Changes in BODE score from pre to post-umeclidinium+vilanterol or flovent

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

Changes in Chronic Respiratory Questionnaire from pre to post-umeclidinium+vilanterol or flovent

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: All COPD SubjectsExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Arnuity Ellipta

2017

N/A

~340

0 / 5Eligibility criteria met