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Bronchodilator

Anoro + Arnuity for COPD

Q: Are there any medical restrictions for volunteers in this clinical trial?

This clinical trial is only open to those who have <a href="https://www.withpower.com/clinical-trials/copd">COPD</a> and are between 18-85 years old. There are a total of 95 spots available.

Q: How many patients will be included in this research project?

That is correct, the information available on clinicaltrials.gov indicates that this trial is still enrolling patients. The study was first posted on November 5th, 2017 and has been updated as recently as May 3rd, 2022. Presently, the study is recruiting for 95 patients from 1 location.

Q: Has this particular medication been federally approved in the United States?

While there is some evidence safety, as this treatment is still in Phase 2 of clinical trials, the Power team can only rate it a 2.

Q: Are there still spots open for volunteers in this experiment?

That is correct, the online information on clinicaltrials.gov does show that this trial is currently looking for participants. The study was originally posted on November 5th, 2017 and was updated as recently as May 3rd, 2022. They are hoping to find 95 patients from a single site.

Q: What are the most popular indications for this medication?

In addition to seasonal allergic rhinitis, this treatment can also improve symptoms for patients with chronic obstructive airway disease, perennial allergic rhinitis (par), and <a href="https://www.withpower.com/clinical-trials/asthma">asthma</a>.

Q: Could elderly patients potentially benefit from this clinical trial?

In order to participate in this trial, patients must fall between the ages of 18-85. There are 37 clinical trials for patients under the age of 18 and 488 for patients over 65.

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 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

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

756 Previous Clinical Trials

1,245,211 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any medical restrictions for volunteers in this clinical trial?

"This clinical trial is only open to those who have COPD and are between 18-85 years old. There are a total of 95 spots available."

Answered by AI

How many patients will be included in this research project?

"That is correct, the information available on clinicaltrials.gov indicates that this trial is still enrolling patients. The study was first posted on November 5th, 2017 and has been updated as recently as May 3rd, 2022. Presently, the study is recruiting for 95 patients from 1 location."

Answered by AI

Has this particular medication been federally approved in the United States?

"While there is some evidence safety, as this treatment is still in Phase 2 of clinical trials, the Power team can only rate it a 2."

Answered by AI

Are there still spots open for volunteers in this experiment?

"That is correct, the online information on clinicaltrials.gov does show that this trial is currently looking for participants. The study was originally posted on November 5th, 2017 and was updated as recently as May 3rd, 2022. They are hoping to find 95 patients from a single site."

Answered by AI

What are the most popular indications for this medication?

"In addition to seasonal allergic rhinitis, this treatment can also improve symptoms for patients with chronic obstructive airway disease, perennial allergic rhinitis (par), and asthma."

Answered by AI

Could elderly patients potentially benefit from this clinical trial?

"In order to participate in this trial, patients must fall between the ages of 18-85. There are 37 clinical trials for patients under the age of 18 and 488 for patients over 65."

Answered by AI