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Bronchodilator

Umeclidinium bromide/vilanterol for Chronic Obstructive Pulmonary Disease

Phase 4
Waitlist Available
Led By Gary L Pierce, PhD
Research Sponsored by Gary L. Pierce
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

Summary

The goal of this study is to evaluate the acute effects of a long-acting bronchodilator on pulmonary function, vascular function and muscle sympathetic nerve activity in individuals with COPD. Individuals will be recruited from previous pulmonary research cohorts at The University of Iowa hospitals and clinics. Individuals that are interested in the study and are deemed eligible to participate will have a total of 3 visits to the laboratory, which includes the screening and consent (visit 1) that will last approximately 1 hour. Visits 2 and 3 are experimental visits and will be more extensive (\~4 hours). Participants will be randomized to receive either a long-acting bronchodilator or a placebo inhaler at the first experimental visit, followed by either the placebo inhaler or the long-acting bronchodilator at the second experimental visit. Assessments of pulmonary function, vascular function (via non-invasive, well-established techniques), and muscle sympathetic nerve activity will be performed at both experimental visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Aortic stiffness
Carotid artery stiffness

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Umeclidinium bromide/vilanterolActive Control1 Intervention
Umeclidinium bromide/vilanterol (umeclidinium bromide 62.5 mcg; vilanterol 25mcg inhalation powder; trade name Anoro Ellipta) is a combination long-acting bronchodilator that acts to reduce the amount of air trapped in the lungs at the end of of expiration.
Group II: PlaceboPlacebo Group1 Intervention
A placebo inhaler will be administered to serve as a control comparator to the umeclidinium bromide/vilanterol inhaler.

Find a Location

Who is running the clinical trial?

Gary L. PierceLead Sponsor
4 Previous Clinical Trials
166 Total Patients Enrolled
Gary L Pierce, PhDPrincipal InvestigatorUniversity of Iowa
4 Previous Clinical Trials
249 Total Patients Enrolled
~2 spots leftby Nov 2025