Treatment for Chronic Obstructive Pulmonary Disease (COPD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Roselove NUNOO-ASARE, Keswick, VA
Chronic Obstructive Pulmonary Disease (COPD)+3 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

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

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Eligible Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 8 secondary outcomes in patients with Chronic Obstructive Pulmonary Disease (COPD). Measurement will happen over the course of First baseline only=day 0.

First baseline only=day 0
High resolution CT of lung
Day 67
Changes in BODE score from pre to post-umeclidinium+vilanterol or flovent
Changes in Chronic Respiratory Questionnaire from pre to post-umeclidinium+vilanterol or flovent
Changes in GOLD Stage from pre to post-umeclidinium+vilanterol or flovent
Changes in Saint George's Respiratory Questionnaire from pre to post-umeclidinium+vilanterol or flovent
Changes in Transient Dyspnea Index from pre to post-umeclidinium+vilanterol or flovent
Day 67
Changes in Baseline Dyspnea Index from pre to post-umeclidinium+vilanterol or flovent
Changes in pulmonary Function Test (PFT) from pre to post-umeclidinium+vilanterol or Flovent
Changes in the hyper polarized MRI xenon-129 MRI (HXe MRI) assessment pre-post 30-day treatment of umeclidinium+vilanterol or Flovent

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

0 Treatment Group

This trial requires 95 total participants across 0 different treatment group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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 has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 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.

Who is running the study

Principal Investigator
Y. M. S.
Prof. Y. Michael Shim, MD
University of Virginia

Closest Location

Roselove NUNOO-ASARE - Keswick, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
post bronchodilator PFT spirometry FEV1/FVC < 70% predicted
History of diagnosis of COPD
History of alpha 1 anti-trypsin deficiency

Patient Q&A Section

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Other questions from users

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

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Chronic Obstructive Pulmonary Disease (COPD) by sharing your contact details with the study coordinator.