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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
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

Study 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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with COPD.
Select...
I have a history of alpha 1 anti-trypsin deficiency.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in the hyper polarized MRI xenon-129 MRI (HXe MRI) assessment pre-post 30-day treatment of umeclidinium+vilanterol or Flovent
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
759 Previous Clinical Trials
1,245,531 Total Patients Enrolled
Yun M Shim, MDPrincipal InvestigatorUniversity of Virginia
4 Previous Clinical Trials
1,299 Total Patients Enrolled
Kun Qing, PhDPrincipal InvestigatorUniversity of Virginia

Media Library

Anoro Ellipta (Bronchodilator) Clinical Trial Eligibility Overview. Trial Name: NCT03002389 — Phase 2
Chronic Obstructive Pulmonary Disease Research Study Groups: All COPD Subjects
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Anoro Ellipta Highlights & Side Effects. Trial Name: NCT03002389 — Phase 2
Anoro Ellipta (Bronchodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03002389 — Phase 2
~7 spots leftby Dec 2024
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