CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
Umeclidinium / Vilanterol Dry Powder Inhaler +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03611699
NCT03611699Phase 4Completed

Static Lung Hyperinflation and Sympathetic Nerve Activity-Associated Large Artery Stiffness in COPD Patients

Gary L. Pierce·interventional·Posted Aug 2, 2018·Updated Jul 14, 2020

In Brief

A Phase 4 clinical trial evaluating Umeclidinium / Vilanterol Dry Powder Inhaler and Placebo for COPD. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedAug 2, 2018
Enrollment StartJan 24, 2019
Primary CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.9 years ago

Interventions

Umeclidinium / Vilanterol Dry Powder Inhalerdrug

umeclidinium/vilanterol dry powder inhaler

Placebodrug

Placebo inhaler